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.
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 defect could lead to misinterpretation of images, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Philips Electronics North America Corporation is recalling specific models of INTEGRIS and Allura medical imaging systems. The affected products include the INTEGRIS V5000 (Model 72248), 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. The source text does not specify the number of affected units, specific serial numbers, or the date of the recall.
The recall covers a worldwide distribution, 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 proceed, nor does it report any injuries or illnesses associated with this defect.
The recalled product
- Product
- INTEGRIS V5000: Model Number: 72248 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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