Agency classClass IIOur severity:High FDA (Devices)·Z-0702-2016·Announced 2016-02-10

Philips Allura Xper X-ray Systems Recalled for Image Interpretation Error

Philips is recalling Allura Xper FD10 systems because a software defect may cause still images to be mistaken for live images during cardiovascular procedures.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 during critical procedures. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.

Plain-English summary

Philips Electronics North America Corporation is recalling the Allura Xper FD10, FD10 C, and FD10 F systems. The recall affects 13,297 units distributed worldwide, including the United States, Puerto Rico, and numerous international locations. The affected model numbers are 722026, 722010, 722003, 722002, and 722001.

The recall is due to a defect in how the systems handle live and still images. The use of these systems can lead to still images being interpreted as live images. This error could occur during cardiovascular and vascular X-ray imaging applications, including diagnostic and interventional procedures such as PTCA, stent placement, atherectomies, pacemaker implantations, and ElectroPhysiology (EP).

The source text does not specify the number of reported injuries or illnesses associated with this defect. Users of these systems should contact Philips for instructions on how to resolve the issue.

The recalled product

Product: Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 722002 722001 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker…
Manufacturer: Philips Electronics North America Corporation
Category: Medical Device — Imaging Systems
Hazard: mis-labeling
software-defect
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 →

Same manufacturer · Philips Electronics North America Corporation

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Same hazard · mis labeling