Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Risk
Philips is recalling INTEGRIS and Allura medical imaging systems because software issues may cause still images to be misinterpreted as live images during procedures.
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 a potential for misinterpretation of clinical data, but no specific 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 H5000 (Model 72246), INTEGRIS 3000/5000, 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. The defect can cause still images to be interpreted as live images by the user. This misinterpretation could potentially impact clinical decision-making during procedures.
A total of 13,297 units are affected by this recall. The distribution was worldwide, including the United States (nationwide, including Puerto Rico) and numerous international countries. All serial numbers are included in the recall scope. Users of these systems should contact Philips for further instructions on how to address the issue.
The recalled product
- Product
- INTEGRIS H5000; Model Number: 72246 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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