Philips Allura Xper Biplane OR Table Recall for Image Interpretation Error
Philips is recalling Allura Xper FD20 Biplane OR Tables because still images may be incorrectly interpreted as live images 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: The recall is classified as FDA Class II, and the hazard involves a risk of harm (misinterpretation of medical images) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Philips Electronics North America Corporation is recalling the Allura Xper FD20 Biplane OR Table, model numbers 722025 and 722020. The recall involves 13,297 units distributed worldwide, including the United States, Puerto Rico, and numerous international markets.
The recall was initiated 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 dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures such as angiography, stent placements, and cardiac imaging.
Healthcare facilities and users of these systems should contact Philips for further instructions on how to address the issue. The recall covers all serial numbers for the affected models.
The recalled product
- Product
- Allura Xper FD20 Biplane OR Table; Model Numbers: 722025 722020 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent…
- 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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