Allura Xper FD20 Biplane OR Table (Philips) – Battery Depletion Risk (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
Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Brand
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands
Lot Codes / Batch Numbers
Model Numbers: (1) 722020, (2) 722025, UDI-DI: (1) N/A, (2) 00884838059108, Serial Numbers: (1) 4, (2) 2, 3, 6
Products Sold
Model Numbers: (1) 722020, (2) 722025; UDI-DI: (1) N/A, (2) 00884838059108; Serial Numbers: (1) 4, (2) 2, 3, 6;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands is recalling Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K10200 due to The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the syst. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
Recommended Action
Per FDA guidance
On September 3, 2025, URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: 1. Circulate this Urgent Medical Device Correction letter to all users of the system so that they are aware of the issue. 2. In case the affected system has been transferred to another organization, please send a copy of this Urgent Medical Device Correction letter to that organization and inform Philips about this transfer through your local Philips representative. 3. Keep this Urgent Medical Device Correction letter with the documentation of the system until Philips corrects your system. Ensure that the letter is in a place likely to be seen/viewed. 4. Complete and return the response form included in this Urgent Medical Device Correction to Philips promptly and no later than 30 days from receipt. 5. If you experience the issue described in this letter, please report it to your local Philips representative. Actions to be taken by recalling firm: 1. Philips will replace the BIOS battery in all affected systems. 2. Philips expects to start the implementation of this action in affected devices by November 2025. Your local Philips representative will contact you to schedule a visit to perform this activity in your system once available. If you need additional information or support concerning these issues, contact your local Philips representative at 1-800-722-9377 (Philips Customer Care Solutions Center).
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