DigitalDiagnost recallZ-0464-2026 · Philips Medical Systems DMC GmbH · initiated Oct 1, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips Medical Systems DMC GmbH or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
On October 1, 2025, "URGENT MEDICAL DEVICE CORRECTION" letters dated September 30, 2025, were sent to customers. The letters described the problem, product and actions to be taken. Actions to be taken: It is safe to continue to use the system(s) in accordance with the intended use. It is recommended that customers use the motorized movement option until the technical solution has been implemented. The system may experience motor drive errors if the force for movement exceeds 110N, which restricts the motorized movement. If the motorized movement does not function, customers should contact their local service representative. B. Circulate this notice to all users of this device so that they are aware of the issue and associated hazard/harm. C. Please retain this Urgent Medical Device Correction letter with your system(s) until the solution is installed; ensure the notice is in a place likely to be seen/viewed. 5. Actions planned by Philips to correct the problem. Philips will provide the technical solution details when finalized. This notice has been reported to the appropriate Regulatory Agencies. If you need any further information or support concerning this issue, please contact your local Philips representative. For North America, contact the Customer Care Solutions Center (1-800-722-9377, 8AM 8PM EST, Monday-Friday).
Recall details
- Recall number
- Z-0464-2026
- Status
- Open, Classified
- Initiated by the company
- Oct 1, 2025
- Posted by the FDA
- Nov 7, 2025
- Recalling firm
- Philips Medical Systems DMC GmbH
- Quantity
- 12 units
- Product code
- KPR
- FDA submissions
- K210692
- 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, Latvia, Lithuania, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, R¿union, Samoa, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, T¿rkiye, Turkmenistan, United Kingdom, Utd.Arab.Emir.,
Product description
DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032;
Code information (models, lots, serial numbers)
1. Model Number: 712031; UDI-DI: 00884838065321; Serial Numbers: 10001181, 10001182, 10001185, 10001186, 10001188, 10001189, SN16000022, SN20000013; 2. Model Number: 712032; UDI-DI: 00884838074514; Serial Numbers: 10001179, 19000341, 19000342, 19000343;
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- DigitalDiagnost 712031Philips Medical Systems DMC GmbH · Solid state x-ray imager (flat panel/digital imager)2 recalls65 reports
- DigitalDiagnost 712032Philips Medical Systems DMC GmbH · Solid state x-ray imager (flat panel/digital imager)2 recalls10 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 97748).
- Z-0461-2026 · Open, ClassifiedProxiDiagnost N90; Model Number: 706110;
- Z-0462-2026 · Open, ClassifiedCombiDiagnost R90; Model Number: 709031;
- Z-0463-2026 · Open, ClassifiedPrecision CRF; Model Number: 706400;
- Z-0465-2026 · Open, ClassifiedDigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035;
- Z-0466-2026 · Open, ClassifiedRadiography 7300 C; Model Number: 712037;
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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