Philips Allura Xper FD20/10 Recalled for Image Display Error
Philips is recalling 13,297 Allura Xper FD20/10 systems because a software error may cause still images to be interpreted as live images.
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 no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Philips Electronics North America Corporation is recalling 13,297 Allura Xper FD20/10 systems, model number 722029. These are dedicated vascular and neurovascular imaging systems used for diagnostic and interventional procedures, including angiography, stent placements, and cardiac imaging. The recall covers all serial numbers and includes distribution in the United States (nationwide, including Puerto Rico) and numerous countries worldwide.
The recall is being conducted 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 error could potentially affect the interpretation of imaging data during procedures.
Healthcare facilities and users of these systems should contact Philips Electronics North America Corporation for instructions on how to resolve the issue. The source text does not specify a specific action for consumers, as these are professional medical devices.
The recalled product
- Product
- Allura Xper FD20/10; Model Numbers: 722029 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 placements…
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — Imaging System
- 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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