The Recall Desk
HighFDA (Devices)·Z-0713-2016·Announced 2016-02-10

Philips Allura Xper FD20/20 Recall for Image Interpretation Error

Philips is recalling 13,297 Allura Xper FD20/20 systems because a software issue may cause still images to be mistaken for live images during medical 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 is classified as FDA Class II, and the hazard involves a risk of harm (misinterpretation of medical images) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Philips Electronics North America Corporation is recalling 13,297 units of the Allura Xper FD20/20 system, model number 722038. These are dedicated vascular and neurovascular imaging systems used for diagnostic and interventional procedures, including angiography, stent placements, and cardiac imaging.

The recall is due to a software issue where the use of live images and still images can lead to still images being interpreted as live images. This error could affect the accuracy of medical imaging during procedures.

The affected units were distributed worldwide, including the United States (nationwide, including Puerto Rico) and numerous international countries. The recall covers all serial numbers for the specified model. Healthcare facilities should contact Philips for instructions on how to resolve the issue.

The recalled product

Product
Allura Xper FD20/20; Model Number: 722038 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisat
Manufacturer
Philips Electronics North America Corporation
Category
Medical Device — Imaging System
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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