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 high-risk medical device where a software defect could lead to misinterpretation of images, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Philips Electronics North America Corporation is recalling the INTEGRIS BV5000 (Model 72249) and various Allura systems, including the Allura Xper, Clarity, CV, and Centron. The recall involves 13,297 units distributed worldwide, including the United States and Puerto Rico.
The recall was initiated because the use of these systems regarding live and still images can lead to still images being interpreted as live images. This software defect poses a risk of misinterpretation during interventional and diagnostic vascular, neurovascular, and cardiovascular procedures.
Healthcare facilities and consumers who possess these devices should contact Philips Electronics North America Corporation for instructions on how to resolve the issue. The recall covers all serial numbers for the affected models.
The recalled product
- Product
- INTEGRIS BV5000: Model Number: 72249 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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