Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error
Philips is recalling INTEGRIS and Allura medical imaging systems because a software issue may cause still images to be misinterpreted as live images.
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 involves a risk-of-harm product (medical device) where the defect could lead to misdiagnosis, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Philips Electronics North America Corporation is recalling specific models of INTEGRIS and Allura medical imaging systems, including the INTEGRIS BH3000 (Model 72242), INTEGRIS 3000, INTEGRIS 5000, INTEGRIS Allura 9 Biplane, and INTEGRIS Allura 12 & 15. 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 Allura Xper, Allura Clarity, Allura CV, Allura Centron, and UNIQ systems. The issue can cause still images to be interpreted as live images, which may lead to incorrect clinical decisions or misdiagnosis. The source text does not report any specific injuries or illnesses associated with this defect.
Healthcare facilities and users of these systems should contact Philips Electronics North America Corporation for instructions on how to resolve the issue. The recall number is Z-0720-2016.
The recalled product
- Product
- INTEGRIS BH3000; Model Number: 72242 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 and interventional
- 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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