thejoe Philips Medical Systems Gmbh, DMC

Philips Medical Systems Gmbh, DMC: 33 FDA recall reports

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

33Reports

0Class I

3Ongoing

2021-09-08Most 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	33

By year reported

Year	Reports
2018	29
2019	1
2020	2
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.

CombiDiagnost R90 Software Version R1.0 and R1.1

Z-2357-2021 · Class II · reported 2021-09-08 · Ongoing

Why it was recalled: Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter position is changed directly after the Lock-In command. This software issue leads to an over or under exposed image.
Product: CombiDiagnost R90 Software Version R1.0 and R1.1
Where it went: US Nationwide Distribution
How much: 322 systems; 66 in US

CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscop

Z-1328-2020 · Class II · reported 2020-02-26 · Ongoing

Why it was recalled: When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state, requiring the intervention of a service Engineer. Additionally, the thermos switch, which handles power down of the unit in case of transformer overheating, was installed incorrectly at production.
Product: CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
Where it went: Worldwide distribution US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, MI, MN, MO, MT, NC, NJ, NY, OH, TX, UT, VA and countries of Canada, Australia, Austria, Bangladesh, Belgium, Bulgaria, Chile, China, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Dominican Republic, Egypt, Ethiopia, France, Germany, Ghana, Hungary, Iran, Italy, Jordan, Kenya, Kuwait, Latvia, Lebanon, Libya, Luxembourg, Malaysia, Martinique, Mexico, Nepal, Netherlands, New Zealand, Nigeria, Oman, Philippines, Poland, Portugal, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, South Africa, Spain, Switzerland, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Viet Nam.
How much: 116

CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscop

Z-1329-2020 · Class II · reported 2020-02-26 · Ongoing

Why it was recalled: When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state, requiring the intervention of a service Engineer. Additionally, the thermos switch, which handles power down of the unit in case of transformer overheating, was installed incorrectly at production.
Product: CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
Where it went: Worldwide distribution US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, MI, MN, MO, MT, NC, NJ, NY, OH, TX, UT, VA and countries of Canada, Australia, Austria, Bangladesh, Belgium, Bulgaria, Chile, China, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Dominican Republic, Egypt, Ethiopia, France, Germany, Ghana, Hungary, Iran, Italy, Jordan, Kenya, Kuwait, Latvia, Lebanon, Libya, Luxembourg, Malaysia, Martinique, Mexico, Nepal, Netherlands, New Zealand, Nigeria, Oman, Philippines, Poland, Portugal, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, South Africa, Spain, Switzerland, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Viet Nam.
How much: 131

Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System

Z-0612-2019 · Class II · reported 2019-02-20 · Terminated

Why it was recalled: kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.
Product: Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
Where it went: Worldwide Distribution: US (nationwide) to states of: AZ, CA, GA, IL, MN, MO, MT, NJ, OH, TX, UT & VA; and to countries of: Australia, Austria, Bangladesh, Belgium, Chile C¿te D'Ivoire, Czech Republic. Egypt, Ethiopia, France, Germany, Ghana, Iran, Italy, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Martinique, Mexico, Nepal, Netherlands, New Zealand, Philippines, Portugal Russian Federation, Rwanda, Saudi Arabia, Serbia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates and United Kingdom.
How much: 146

Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028, 712029, 7

Z-0239-2019 · Class II · reported 2018-10-31 · Terminated

Why it was recalled: Stitching run on SkyPlate detector interrupted intermittently; Stitching with SkyPlate aborts after first image; System software CD contains wrong baseline
Product: Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028, 712029, 712031, 712032701032, 712033, 712224, 712225, 712226, 712227, 712228.
Where it went: Worldwide distribution - US Nationwide and countries of Canada Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Chile China Colombia Czech Republic Denmark Egypt Finland France French Guiana Germany Guadeloupe Hong Kong Hungary India Indonesia Iran Israel Italy Japan Jordan Korea, Republic of Kuwait Kyrgyzstan Latvia Luxembourg Maldives Martinique Mexico Netherlands New Zealand Norway Panama Peru Poland Portugal Qatar Romania Russian Federation Saudi Arabia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom
How much: 829 units

BuckyDiagnost Ceiling System (Stitching Patient Support) 704031

Z-2846-2018 · Class II · reported 2018-08-29 · Terminated

Why it was recalled: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Product: BuckyDiagnost Ceiling System (Stitching Patient Support) 704031
Where it went: US Nationwide; International to 66 countries

DigitalDiagnost Dual Detector (Stitching Patient Support) 712022

Z-2858-2018 · Class II · reported 2018-08-29 · Terminated

Why it was recalled: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Product: DigitalDiagnost Dual Detector (Stitching Patient Support) 712022
Where it went: US Nationwide; International to 66 countries

DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031

Z-2843-2018 · Class II · reported 2018-08-29 · Terminated

Why it was recalled: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Product: DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031
Where it went: US Nationwide; International to 66 countries

DigitalDiagnost Single Detector (Stitching Patient Support) 712020

Z-2863-2018 · Class II · reported 2018-08-29 · Terminated

Why it was recalled: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Product: DigitalDiagnost Single Detector (Stitching Patient Support) 712020
Where it went: US Nationwide; International to 66 countries

EasyDiagnost Eleva DRF (Stitching Patient Support) 706032

Z-2867-2018 · Class II · reported 2018-08-29 · Terminated

Why it was recalled: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Product: EasyDiagnost Eleva DRF (Stitching Patient Support) 706032
Where it went: US Nationwide; International to 66 countries

DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028

Z-2842-2018 · Class II · reported 2018-08-29 · Terminated

Why it was recalled: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Product: DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028
Where it went: US Nationwide; International to 66 countries
How much: 2 units

DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026

Z-2862-2018 · Class II · reported 2018-08-29 · Terminated

Why it was recalled: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Product: DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026
Where it went: US Nationwide; International to 66 countries

DigitalDiagnost 4.1 Flex / Value (Stitching Patient Support) 712028

Z-2854-2018 · Class II · reported 2018-08-29 · Terminated

Why it was recalled: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Product: DigitalDiagnost 4.1 Flex / Value (Stitching Patient Support) 712028
Where it went: US Nationwide; International to 66 countries

DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027

Z-2851-2018 · Class II · reported 2018-08-29 · Terminated

Why it was recalled: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Product: DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027
Where it went: US Nationwide; International to 66 countries

DigitalDiagnost Release 3 (Stitching Patient Support) 712025

Z-2861-2018 · Class II · reported 2018-08-29 · Terminated

Why it was recalled: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Product: DigitalDiagnost Release 3 (Stitching Patient Support) 712025
Where it went: US Nationwide; International to 66 countries

DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712081

Z-2848-2018 · Class II · reported 2018-08-29 · Terminated

Why it was recalled: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Product: DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712081
Where it went: US Nationwide; International to 66 countries

DigitalDiagnost Release 3 (Stitching Patient Support) 712025

Z-2844-2018 · Class II · reported 2018-08-29 · Terminated

Why it was recalled: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Product: DigitalDiagnost Release 3 (Stitching Patient Support) 712025
Where it went: US Nationwide; International to 66 countries

DigitalDiagnost Upgrades (Stitching Patient Support) 712083

Z-2864-2018 · Class II · reported 2018-08-29 · Terminated

Why it was recalled: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Product: DigitalDiagnost Upgrades (Stitching Patient Support) 712083
Where it went: US Nationwide; International to 66 countries

DigitalDiagnost 4.1 Chest / Emergency (Stitching Patient Support) 712029

Z-2853-2018 · Class II · reported 2018-08-29 · Terminated

Why it was recalled: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Product: DigitalDiagnost 4.1 Chest / Emergency (Stitching Patient Support) 712029
Where it went: US Nationwide; International to 66 countries

DigitalDiagnost, Single-Detect (Stitching Patient Support) 712062

Z-2866-2018 · Class II · reported 2018-08-29 · Terminated

Why it was recalled: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Product: DigitalDiagnost, Single-Detect (Stitching Patient Support) 712062
Where it went: US Nationwide; International to 66 countries

DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082

Z-2841-2018 · Class II · reported 2018-08-29 · Terminated

Why it was recalled: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Product: DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082
Where it went: US Nationwide; International to 66 countries
How much: 2 units

DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026

Z-2845-2018 · Class II · reported 2018-08-29 · Terminated

Why it was recalled: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Product: DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026
Where it went: US Nationwide; International to 66 countries

DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029

Z-2849-2018 · Class II · reported 2018-08-29 · Terminated

Why it was recalled: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Product: DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029
Where it went: US Nationwide; International to 66 countries

EasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050

Z-2868-2018 · Class II · reported 2018-08-29 · Terminated

Why it was recalled: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Product: EasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050
Where it went: US Nationwide; International to 66 countries

DigitalDiagnost 4.1 (Stitching Patient Support) 712225

Z-2852-2018 · Class II · reported 2018-08-29 · Terminated

Why it was recalled: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Product: DigitalDiagnost 4.1 (Stitching Patient Support) 712225
Where it went: US Nationwide; International to 66 countries

DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081

Z-2856-2018 · Class II · reported 2018-08-29 · Terminated

Why it was recalled: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Product: DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081
Where it went: US Nationwide; International to 66 countries

CombiDiagnost R90 (Stitching Patient Support) 709030

Z-2847-2018 · Class II · reported 2018-08-29 · Terminated

Why it was recalled: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Product: CombiDiagnost R90 (Stitching Patient Support) 709030
Where it went: US Nationwide; International to 66 countries

DigitalDiagnost Classic, Dual-Detector (Stitching Patient Support) 712052

Z-2857-2018 · Class II · reported 2018-08-29 · Terminated

Why it was recalled: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Product: DigitalDiagnost Classic, Dual-Detector (Stitching Patient Support) 712052
Where it went: US Nationwide; International to 66 countries

DigitalDiagnost Dual Detector (Stitching Patient Support) 712022

Z-2859-2018 · Class II · reported 2018-08-29 · Terminated

Why it was recalled: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Product: DigitalDiagnost Dual Detector (Stitching Patient Support) 712022
Where it went: US Nationwide; International to 66 countries

DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028

Z-2850-2018 · Class II · reported 2018-08-29 · Terminated

Why it was recalled: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Product: DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028
Where it went: US Nationwide; International to 66 countries

Showing the 30 most recent of 33. 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.

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