Philips INTEGRIS Allura X-Ray Systems Recalled for Image Display Error
Philips is recalling INTEGRIS Allura X-ray systems because a software error may cause still images to be displayed as live images, potentially leading to misinterpretation.
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 involves a risk-of-harm product (medical device) where the hazard is the potential for misinterpretation of images, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Philips Electronics North America Corporation is recalling the INTEGRIS Allura 15-12 (biplane) and related Allura Xper, Allura Clarity, Allura CV, and Allura Centron systems. The recall involves 13,297 units distributed worldwide, including the United States, Puerto Rico, and numerous international markets.
The recall is due to a software defect affecting the display of live and still images. The issue can cause still images to be interpreted as live images by the user. This error may occur during the use of the systems for diagnostic and interventional procedures.
Healthcare facilities and users should contact Philips for further instructions on how to resolve the issue. The recall number is Z-0728-2016.
The recalled product
- Product
- INTEGRIS Allura 15-12 (biplane); Product Code: 722044 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular…
- 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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