Philips Allura Xper FD20 patient table brake may fail to engage after software update
Philips Allura Xper FD20 X-ray systems with ADN7NT patient tables may have a pivot brake failure after software upgrade 8.1.100 is installed. This could cause unexpected table movements during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall involving a risk-of-harm medical device hazard (brake failure causing unexpected patient table movements) with no reported injuries, meeting the rubric criterion for High severity.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling Philips Allura Xper FD20 X-ray systems equipped with an ADN7NT (non-tilt) patient table. The recall affects the system with Model Number 722012 and Software Version 8.1.100.
When Software upgrade 8.1.100 is installed on these systems, the pivot brake may fail to engage properly. This malfunction could cause unexpected movements of the patient table during clinical use.
The recalling firm has distributed one unit in the United States, and additional units in India, Spain, and the United Arab Emirates.
Affected facilities should stop using the affected equipment and contact Philips Medical Systems Nederland B.V. for guidance on corrective actions.
The recalled product
- Product
- Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100.
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Affected units
- 1
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 (3)
- Product number: 722012
- UDI/DI: 00884838059054
- Serial Number: 2138.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 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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