thejoe Philips Medical Systems Nederlands

Philips Medical Systems Nederlands: 79 FDA recall reports

Every medical device recall the FDA has published for Philips Medical Systems Nederlands. The fault, and how the agency graded it.

79Reports

0Class I

0Ongoing

2021-06-30Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	79

By year reported

Year	Reports
2018	9
2019	69
2021	1

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722

Z-1904-2021 · Class II · reported 2021-06-30 · Terminated

Why it was recalled: Certain low-voltage DC power supplies (DCPS) used in these products may be subject to an increased probability of failure. Failure of a DCPS may result in the sudden loss of imaging functionality or mechanical movement, depending on what subsystems the DCPS is powering.
Product: Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058.
Where it went: Worldwide distribution. US states of: AL, AZ, FL, GA, IL, MA, MO, NJ, OR, and VA; Netherlands, United Kingdom, Poland, Spain, France, Czech Republic, India, Brazil, Singapore, Japan, Colombia, United Arab Emirates, China, Russian Federation, Oman, and Mexico.
How much: 42 devices

Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2

Z-1997-2019 · Class II · reported 2019-08-07 · Terminated

Why it was recalled: Philips has discovered through customer complaints and internal testing an intermittent electronic product defect in accordance with 21 CFR 1003.2(b)(1). When performing Cine runs, the Azurion's automatic exposure control software may set technique factors that result in radiation emissions too low to obtain useful diagnostic images.
Product: Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
Where it went: Nationwide
How much: 229

Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR

Z-1240-2019 · Class II · reported 2019-05-08 · Terminated

Why it was recalled: Magnet Energization Device (MED) can have a residual voltage on output terminal, may cause electrical shocks to personnel servicing the MED, MDD or connected cabling.
Product: Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR systems are indicated for use as a diagnostic device. The purpose of the MED is to supply power to charge the magnet. MED is abbreviation for Magnet Energize Device
Where it went: US Distribution to state of: FL and Internationally to: Switzerland and Germany.
How much: 4 units

Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Produ

Z-1140-2019 · Class II · reported 2019-04-24 · Terminated

Why it was recalled: Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This might cause an intermittent or continuous inability of making live fluoroscopy images or exposures.
Product: Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Product The Allura Xper FD Series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.
Where it went: US Nationwide Distribution in the states of CA, FL, MI, OR, PA, TX and WA.
How much: 7209 total

Foot Switches used with the following systems: 722001 Allura Xper FD 10 C 722002 Allura Xper FD10 F 7220

Z-1141-2019 · Class II · reported 2019-04-24 · Terminated

Why it was recalled: Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This might cause an intermittent or continuous inability of making live fluoroscopy images or exposures.
Product: Foot Switches used with the following systems: 722001 Allura Xper FD 10 C 722002 Allura Xper FD10 F 722003 Allura Xper FD10 722005 Allura Xper FD10/10 722006 Allura Xper FD20 722008 Allura Xper FD20 Biplane 722010 Allura Xper FD10 722011 Allura Xper FD10/10 722012 Allura Xper FD20 722013 Allura XPER FD20 BIPLANE 722014 Allura Xper FD10 OR Table 722015 Allura Xper FD20 OR Table 722019 Allura Xper FD10/10 OR Table 722020 Allura Xper FD20 Biplane OR Table 722022 Allura Xper FD10 OR Table 722023 Allura Xper FD20 OR Table 722024 Allura Xper FD10/10 OR Table 722025 Allura Xper FD20 Biplane OR Table 722026 Allura Xper FD10 722027 Allura Xper FD10/10 722028 Allura Xper FD20 722029 Allura Xper FD20/10 722031 Allura CV20 722033 Allura Xper FD10 OR Table 722034 Allura Xper FD10/10 OR Table 722035 Allura Xper FD20 OR Table 722036 Allura Xper FD20/10 OR Table 722038 Allura Xper FD20/20 722039 Allura Xper FD20/20 OR Table 722058 Allura Xper FD20/15 722059 Allura Xper FD20/15 OR Table 722123 Field extensions Xper cardio 722124 Field extensions Xper vascular 722126 SmartPath to upgrade Allura to AlluraClarity cardio 722127 SmartPath to upgrade Allura to...
Where it went: US Nationwide Distribution in the states of CA, FL, MI, OR, PA, TX and WA.
How much: 7209 total

Achieva XR 1.5T/3.0T, Model Number 781153. Nuclear Magnetic Resonance Imaging System

Z-0884-2019 · Class II · reported 2019-03-06 · Terminated

Why it was recalled: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Product: Achieva XR 1.5T/3.0T, Model Number 781153. Nuclear Magnetic Resonance Imaging System
Where it went: U.S. Nationwide distribution.
How much: 11226 total

SmartPath to dStream for XR and 3.0T, Model Number 781270. Nuclear Magnetic Resonance Imaging System

Z-0903-2019 · Class II · reported 2019-03-06 · Terminated

Why it was recalled: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Product: SmartPath to dStream for XR and 3.0T, Model Number 781270. Nuclear Magnetic Resonance Imaging System
Where it went: U.S. Nationwide distribution.
How much: 11226 total

Intera 1.5T Achieva CV Nova, Model Number 781174. Nuclear Magnetic Resonance Imaging System

Z-0890-2019 · Class II · reported 2019-03-06 · Terminated

Why it was recalled: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Product: Intera 1.5T Achieva CV Nova, Model Number 781174. Nuclear Magnetic Resonance Imaging System
Where it went: U.S. Nationwide distribution.
How much: 11226 total

Enterprise 1.5T, Model Number 781145. Nuclear Magnetic Resonance Imaging System

Z-0882-2019 · Class II · reported 2019-03-06 · Terminated

Why it was recalled: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Product: Enterprise 1.5T, Model Number 781145. Nuclear Magnetic Resonance Imaging System
Where it went: U.S. Nationwide distribution.
How much: 11226 total

SmartPath to dStream for 1.5T, Model Number 781260. Nuclear Magnetic Resonance Imaging System

Z-0900-2019 · Class II · reported 2019-03-06 · Terminated

Why it was recalled: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Product: SmartPath to dStream for 1.5T, Model Number 781260. Nuclear Magnetic Resonance Imaging System
Where it went: U.S. Nationwide distribution.
How much: 11226 total

Intera 1.0T Power/Pulsar, Model Number 781103. Nuclear Magnetic Resonance Imaging System

Z-0876-2019 · Class II · reported 2019-03-06 · Terminated

Why it was recalled: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Product: Intera 1.0T Power/Pulsar, Model Number 781103. Nuclear Magnetic Resonance Imaging System
Where it went: U.S. Nationwide distribution.
How much: 11226 total

Ingenia Elition X, Model Number 781358. Nuclear Magnetic Resonance Imaging System

Z-0923-2019 · Class II · reported 2019-03-06 · Terminated

Why it was recalled: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Product: Ingenia Elition X, Model Number 781358. Nuclear Magnetic Resonance Imaging System
Where it went: U.S. Nationwide distribution.
How much: 11226 total

Ingenia 3.0T, Model Number 781342. Nuclear Magnetic Resonance Imaging System

Z-0911-2019 · Class II · reported 2019-03-06 · Terminated

Why it was recalled: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Product: Ingenia 3.0T, Model Number 781342. Nuclear Magnetic Resonance Imaging System
Where it went: U.S. Nationwide distribution.
How much: 11226 total

MR RT, Model Number 781439. Nuclear Magnetic Resonance Imaging System

Z-0926-2019 · Class II · reported 2019-03-06 · Terminated

Why it was recalled: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Product: MR RT, Model Number 781439. Nuclear Magnetic Resonance Imaging System
Where it went: U.S. Nationwide distribution.
How much: 11226 total

Achieva 1.5T, Model Number 781296. Nuclear Magnetic Resonance Imaging System

Z-0909-2019 · Class II · reported 2019-03-06 · Terminated

Why it was recalled: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Product: Achieva 1.5T, Model Number 781296. Nuclear Magnetic Resonance Imaging System
Where it went: U.S. Nationwide distribution.
How much: 11226 total

Intera Achieva 1.5T Nova, Model Number 781172. Nuclear Magnetic Resonance Imaging System

Z-0888-2019 · Class II · reported 2019-03-06 · Terminated

Why it was recalled: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Product: Intera Achieva 1.5T Nova, Model Number 781172. Nuclear Magnetic Resonance Imaging System
Where it went: U.S. Nationwide distribution.
How much: 11226 total

Achieva 1.5T Conversion, Model Number 781283. Nuclear Magnetic Resonance Imaging System

Z-0907-2019 · Class II · reported 2019-03-06 · Terminated

Why it was recalled: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Product: Achieva 1.5T Conversion, Model Number 781283. Nuclear Magnetic Resonance Imaging System
Where it went: U.S. Nationwide distribution.
How much: 11226 total

Intera 1.5T Explorer/Nova Dual, Model Number 781108. Nuclear Magnetic Resonance Imaging System

Z-0881-2019 · Class II · reported 2019-03-06 · Terminated

Why it was recalled: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Product: Intera 1.5T Explorer/Nova Dual, Model Number 781108. Nuclear Magnetic Resonance Imaging System
Where it went: U.S. Nationwide distribution.
How much: 11226 total

Multiva 1.5T 8 R5 (ZBO), Model Number 781072. Nuclear Magnetic Resonance Imaging System

Z-0871-2019 · Class II · reported 2019-03-06 · Terminated

Why it was recalled: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Product: Multiva 1.5T 8 R5 (ZBO), Model Number 781072. Nuclear Magnetic Resonance Imaging System
Where it went: U.S. Nationwide distribution.
How much: 11226 total

Intera Achieva 1.5T Nova Dual, Model Number 781173. Nuclear Magnetic Resonance Imaging System

Z-0889-2019 · Class II · reported 2019-03-06 · Terminated

Why it was recalled: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Product: Intera Achieva 1.5T Nova Dual, Model Number 781173. Nuclear Magnetic Resonance Imaging System
Where it went: U.S. Nationwide distribution.
How much: 11226 total

Achieva 3.0T TX, Model Number 781345. Nuclear Magnetic Resonance Imaging System

Z-0914-2019 · Class II · reported 2019-03-06 · Terminated

Why it was recalled: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Product: Achieva 3.0T TX, Model Number 781345. Nuclear Magnetic Resonance Imaging System
Where it went: U.S. Nationwide distribution.
How much: 11226 total

Multiva 1.5T 8 R5, Model Number 781074. Nuclear Magnetic Resonance Imaging System

Z-0931-2019 · Class II · reported 2019-03-06 · Terminated

Why it was recalled: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Product: Multiva 1.5T 8 R5, Model Number 781074. Nuclear Magnetic Resonance Imaging System
Where it went: U.S. Nationwide distribution.
How much: 11226 total

Intera 1.5T, Model Number 781195. Nuclear Magnetic Resonance Imaging System

Z-0895-2019 · Class II · reported 2019-03-06 · Terminated

Why it was recalled: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Product: Intera 1.5T, Model Number 781195. Nuclear Magnetic Resonance Imaging System
Where it went: U.S. Nationwide distribution.
How much: 11226 total

Intera Achieva 1.5T Pulsar, Model Number 781171. Nuclear Magnetic Resonance Imaging System

Z-0887-2019 · Class II · reported 2019-03-06 · Terminated

Why it was recalled: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Product: Intera Achieva 1.5T Pulsar, Model Number 781171. Nuclear Magnetic Resonance Imaging System
Where it went: U.S. Nationwide distribution.
How much: 11226 total

Multiva 1.5T 16 R5 (ZBO), Model Number 781073. Nuclear Magnetic Resonance Imaging System

Z-0872-2019 · Class II · reported 2019-03-06 · Terminated

Why it was recalled: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Product: Multiva 1.5T 16 R5 (ZBO), Model Number 781073. Nuclear Magnetic Resonance Imaging System
Where it went: U.S. Nationwide distribution.
How much: 11226 total

Ingenia 1.5T CX (ZBO), Model Number 781262. Nuclear Magnetic Resonance Imaging System

Z-0902-2019 · Class II · reported 2019-03-06 · Terminated

Why it was recalled: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Product: Ingenia 1.5T CX (ZBO), Model Number 781262. Nuclear Magnetic Resonance Imaging System
Where it went: U.S. Nationwide distribution.
How much: 11226 total

Intera 1.5T R11, Model Number 781170. Nuclear Magnetic Resonance Imaging System

Z-0886-2019 · Class II · reported 2019-03-06 · Terminated

Why it was recalled: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Product: Intera 1.5T R11, Model Number 781170. Nuclear Magnetic Resonance Imaging System
Where it went: U.S. Nationwide distribution.
How much: 11226 total

Achieva 3.0T X-series, Model Number 781277. Nuclear Magnetic Resonance Imaging System

Z-0905-2019 · Class II · reported 2019-03-06 · Terminated

Why it was recalled: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Product: Achieva 3.0T X-series, Model Number 781277. Nuclear Magnetic Resonance Imaging System
Where it went: U.S. Nationwide distribution.
How much: 11226 total

Ingenia 1.5T, Model Number 781396. Nuclear Magnetic Resonance Imaging System

Z-0919-2019 · Class II · reported 2019-03-06 · Terminated

Why it was recalled: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Product: Ingenia 1.5T, Model Number 781396. Nuclear Magnetic Resonance Imaging System
Where it went: U.S. Nationwide distribution.
How much: 11226 total

Achieva 7.0T, Model Number 781240. Nuclear Magnetic Resonance Imaging System

Z-0897-2019 · Class II · reported 2019-03-06 · Terminated

Why it was recalled: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Product: Achieva 7.0T, Model Number 781240. Nuclear Magnetic Resonance Imaging System
Where it went: U.S. Nationwide distribution.
How much: 11226 total

Showing the 30 most recent of 79. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

← All device recalls