DigitalDiagnost 4 (Philips) – carriage movement issue (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032;
Brand
Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany
Lot Codes / Batch 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
Products Sold
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;
Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany is recalling DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032; due to Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertic. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026