Philips Allura Xper FD10 system pivot brake failure after software update
Philips is recalling Allura Xper FD10 medical imaging systems with software version 8.1.100 because the pivot brake may fail to engage, potentially causing unexpected table movements during procedures.
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: This recall is classified as High because the equipment poses a potential risk of patient harm through unexpected table movements during medical imaging procedures, but no injuries have been reported to date. The malfunction is triggered by installation of a specific software version.
Plain-English summary
Philips Medical Systems is recalling certain Allura Xper FD10 medical imaging systems (Model 722010, Software Version 8.1.100) equipped with an ADN7NT patient table. Three units have been distributed outside the United States to facilities in India, Spain, and the United Arab Emirates.
When software upgrade 8.1.100 is installed on the Allura Xper with the ADN7NT table, the pivot brake fails to engage. This malfunction may cause unexpected movements of the patient table during medical imaging procedures.
This is a Class II recall from the FDA. No injuries or illnesses have been reported in connection with this issue. Affected systems can be identified by serial numbers 774, 909, and 526.
The recalled product
- Product
- Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100.
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Affected units
- 3
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 (5)
- Product number: 722010
- UDI/DI: 00884838059030
- Serial Numbers: 774
- 909
- 526.
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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