Hamburg, Germany
Philips Medical Systems Gmbh, DMC recalls
7 recalls recorded since 2018, most recently on 1 October 2025. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls7
Ongoing (FDA)4
Terminated or completed3
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 1 October 2025
- Reason
- Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.
- Distribution
- Worldwide Distribution: US (Nationwide) Distribution and OUS (International) countries of: Australia, Austria, Bahrain, Belgium, Bosnia-Herz., Canada, Chile, Croatia, Denmark, Estonia, Finland, France, Germany, Ghana, Gibraltar, Guadeloupe, Indonesia, Iraq, Israel, Italy, Jordan, Kuwait, Kyrgyzstan,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0466-2026, Z-0465-2026, Z-0463-2026, Z-0461-2026, Z-0462-2026, Z-0464-2026
- Radiography 7300 C; Model Number: 712037;
- DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035;
- Precision CRF; Model Number: 706400;
- ProxiDiagnost N90; Model Number: 706110;
- CombiDiagnost R90; Model Number: 709031;
- DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032;
Ongoing Class II Medical devices
- Recall started
- 19 May 2021
- Reason
- Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. (Updated 1/30/23) Expansion of the root cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting.
- Distribution
- US Nationwide Distribution
- Initiated
- FDA Mandated
- Recall numbers
- Z-1326-2022, Z-1325-2022, Z-1328-2022, Z-1329-2022, Z-1327-2022
- DigitalDiagnost 4 High Performance. radiography and fluoroscopy system
- ProxiDiagnost N90. radiography and fluoroscopy system
- DigitalDiagnost C90 High Performance. radiography and fluoroscopy system
- DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system
- DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system
Ongoing Class II Medical devices
- Recall started
- 22 July 2020
- Reason
- 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.
- Distribution
- US Nationwide Distribution
- Initiated
- FDA Mandated
- Recall number
- Z-2357-2021
- CombiDiagnost R90 Software Version R1.0 and R1.1
Ongoing Class II Medical devices
- Recall started
- 19 December 2019
- Terminated
- 18 June 2020
- Reason
- 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.
- Distribution
- 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, E
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1328-2020, Z-1329-2020
- CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
- CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
Terminated Class II Medical devices
- Recall started
- 7 November 2018
- Terminated
- 2 September 2020
- Reason
- kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.
- Distribution
- 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, Malaysi
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0612-2019
- Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
Terminated Class II Medical devices
- Recall started
- 19 September 2018
- Terminated
- 10 August 2023
- Reason
- Stitching run on SkyPlate detector interrupted intermittently; Stitching with SkyPlate aborts after first image; System software CD contains wrong baseline
- Distribution
- 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 Ital
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0239-2019
- 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.
Terminated Class II Medical devices
- Recall started
- 27 June 2018
- Terminated
- 30 April 2024
- Reason
- 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.
- Distribution
- US Nationwide; International to 66 countries
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2846-2018, Z-2858-2018, Z-2843-2018, Z-2863-2018, Z-2867-2018, Z-2842-2018, Z-2862-2018, Z-2854-2018, Z-2851-2018, Z-2861-2018, Z-2848-2018, Z-2844-2018 and 16 more
- BuckyDiagnost Ceiling System (Stitching Patient Support) 704031
- DigitalDiagnost Dual Detector (Stitching Patient Support) 712022
- DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031
- DigitalDiagnost Single Detector (Stitching Patient Support) 712020
- EasyDiagnost Eleva DRF (Stitching Patient Support) 706032
- DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028
- DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026
- DigitalDiagnost 4.1 Flex / Value (Stitching Patient Support) 712028
- and 20 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.