Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error
Philips is recalling INTEGRIS and Allura systems because a software issue may cause still images to be mistaken for live images during 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 involves a risk-of-harm product (medical device) where the hazard is the 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 13,297 units of the INTEGRIS BH5000 (Model 72247) and various Allura systems. The affected products include the INTEGRIS 3000, 5000, Allura 9 Biplane, Allura 12, and Allura 15 systems, which are intended for interventional and diagnostic vascular, neurovascular, and cardiovascular procedures.
The recall is due to a software issue in the Allura Xper, Allura Clarity, Allura CV, Allura Centron, and UNIQ systems. This issue can cause still images to be interpreted as live images, potentially leading to misinterpretation of patient data during medical procedures.
The affected units were distributed worldwide, including the United States (nationwide, including Puerto Rico) and numerous international countries. All serial numbers are affected. Healthcare providers should contact Philips for instructions on how to resolve the issue.
The recalled product
- Product
- INTEGRIS BH5000; Model Number: 72247 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
- Hazard
- 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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