Allura Xper FD20/20 systems recalled over battery, drive and power supply deterioration
Philips Allura Xper FD20/20 systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 75 units are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; loss of motorized movement during an interventional procedure is a potential harm and no injuries are reported.
Plain-English summary
The Philips Allura Xper FD20/20, product code 722038, UDI-DI 00884838054226, is being recalled. Affected serial numbers include 39, 63, 42, 55, 67, 99, 60, 71, 115, 78 and 106, with the full list in the recall notice. The recall covers 75 units, of which 26 are in the United States and 49 outside it.
Systems may not perform as intended because of deterioration of certain internal components: the CMOS battery, hard disk drive and/or power supply unit. If this deterioration occurs, motorized movements of the system become unavailable, leaving only manual movements of the stand and table. The FDA classified the action as Class II.
Imaging sites operating these systems should follow the manufacturer's instructions for inspection and correction.
The recalled product
- Product
- Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Category
- Medical Device — Imaging System
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Product Code: 722038
- UDI-DI: 00884838054226
- Serial numbers: 39
- 63
- 42
- 55
- 67
- 99
- 60
- 71
- 115
- 78
- 106
- 118
- 130
- 49
- 119
- 126
- 173
- 37
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 13 products in this recall →Related recalls
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