Philips Allura Xper OR Table Recall for Image Interpretation Error
Philips is recalling Allura Xper FD10 OR Tables because still images may be misinterpreted as live images during cardiovascular 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: The recall is classified as FDA Class II, and the hazard involves a risk of harm (misinterpretation of medical images) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Philips Electronics North America Corporation is recalling the Allura Xper FD10 OR Table, model numbers 722033 and 722022. The recall involves 13,297 units distributed worldwide, including the United States, Puerto Rico, and numerous international markets.
The recall was issued because the use of Allura Xper, Allura Clarity, Allura CV, Allura Centron, and UNIQ systems regarding live and still images can lead to still images being interpreted as live images. This defect affects the intended use of the device for cardiovascular and vascular X-ray imaging applications, including diagnostic and interventional procedures such as PTCA, stent placement, atherectomies, pacemaker implantations, and ElectroPhysiology (EP).
Healthcare facilities and users of these specific model numbers should contact Philips for further instructions on how to address the issue. The source text does not specify a particular action for consumers, as these are professional medical devices.
The recalled product
- Product
- Allura Xper FD10 OR Table; Model Numbers: 722033 722022 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP).
- Manufacturer
- Philips Electronics North America Corporation
- Affected units
- 13,297
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 (1)
- All serial numbers
Distribution
Part of a larger recall action
This product is one of 29 recalled by Philips Electronics North America Corporation 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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