Allura Xper FD20 OR Table recalled over CMOS battery and drive deterioration
Philips Allura Xper FD20 OR Table systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 174 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 OR Table is being recalled under product codes 722023, 722035 and 722015, with UDI-DI numbers 00884838059085 and 00884838054240 and the serial numbers listed in the recall notice. The recall covers 174 units, of which 45 are in the United States and 129 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 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; 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 Codes: (1)722023
- (2) 722035
- (3) 722015
- UDI-DI: (1) 00884838059085
- (2) 00884838054240
- (3) N/A
- Serial numbers: (1) 27
- 116
- 12
- 175
- 98
- 35
- 142
- 179
- 46
- 64
- 110
- 124
- 66
- 117
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.
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