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 mistaken for 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 misinterpretation of medical images which could lead to harm, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Philips Electronics North America Corporation is recalling specific models of the INTEGRIS and Allura medical imaging systems. The affected products include the INTEGRIS BN/BV3000 (Model 72240), INTEGRIS 3000, INTEGRIS 5000, INTEGRIS Allura 9 Biplane, and INTEGRIS Allura 12 & 15 systems. These devices are intended for interventional and diagnostic vascular, neurovascular, and cardiovascular procedures.
The recall is due to a software issue affecting the Allura Xper, Allura Clarity, Allura CV, Allura Centron, and UNIQ systems. This issue can lead to still images being interpreted as live images by the user. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
The recall covers 13,297 units distributed worldwide, including the United States (nationwide, including Puerto Rico) and numerous international countries. The source text does not provide specific instructions for consumers or healthcare providers on how to resolve the issue, but the recall is active under FDA Class II classification.
The recalled product
- Product
- INTEGRIS BN/BV3000; Model Number: 72240 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…
- 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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