The Recall Desk
HighFDA (Devices)·Z-0728-2016·Announced 2016-02-10

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 potential for 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 the INTEGRIS Allura 15-12 (biplane) and related Allura Xper, Allura Clarity, Allura CV, and Allura Centron systems. The recall involves 13,297 units distributed worldwide, including the United States, Puerto Rico, and numerous international markets.

The recall is due to a software defect affecting the display of live and still images. The issue can cause still images to be interpreted as live images by the user. This error may occur during the use of the systems for diagnostic and interventional procedures.

Healthcare facilities and users should contact Philips for further instructions on how to resolve the issue. The recall number is Z-0728-2016.

The recalled product

Product
INTEGRIS Allura 15-12 (biplane); Product Code: 722044 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 a
Manufacturer
Philips Electronics North America Corporation
Category
Medical Device — X-Ray 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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 29 products in this recall →

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