Philips UNIQ and Allura Systems Recalled for Image Interpretation Error
Philips is recalling UNIQ and Allura imaging systems because still images may be misinterpreted as live images during medical procedures.
What this means for you
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. The hazard involves a risk of harm (misinterpretation of medical images) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Philips Electronics North America Corporation is recalling 13,297 units of UNIQ FD (Model 722028) and Allura Xper, Allura Clarity, Allura CV, and Allura Centron systems. The recall covers all serial numbers and includes distribution in the United States (including Puerto Rico) and numerous countries worldwide.
The recall is issued because the use of these systems regarding live images and still images can lead to still images being interpreted as live images. This defect affects vascular, cardiovascular, and neurovascular imaging applications, including diagnostic, interventional, and minimally invasive procedures.
Healthcare facilities and users of these devices should contact Philips for instructions on how to address the issue. The source text does not specify a specific consumer action for individual patients, but the defect impacts the interpretation of medical imaging data.
The recalled product
- Product
- UNIQ FD; Model Numbers: 722028 The Philips UNIQ is intended for use on human patients to perform: " Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebra
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — Imaging Systems
- 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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