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.
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 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 implantati
- 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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