Philips INTEGRIS Allura X-ray Systems Recalled for Image Display Error
Philips is recalling INTEGRIS Allura X-ray systems because a software error may cause still images to be displayed as live images, potentially leading to misinterpretation.
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, which could lead to incorrect medical decisions, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Philips Electronics North America Corporation is recalling the INTEGRIS Allura 15-12 (mono) X-ray system, model number 722043. The recall affects 13,297 units distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as numerous international markets.
The recall is issued because the use of Allura Xper, Allura Clarity, Allura CV, Allura Centron, and UNIQ systems regarding live and still images can lead to still images being interpreted as live images. This error may affect the accuracy of diagnostic and interventional procedures.
Healthcare facilities and users should contact Philips for instructions on how to address the issue. The source text does not specify a remediation method or timeline.
The recalled product
- Product
- INTEGRIS Allura 15-12 (mono); Model Number: 722043 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
- 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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