Philips Allura Xper FD20/15 Recall for Image Display Error
Philips is recalling 13,297 Allura Xper FD20/15 systems worldwide because a software error may cause still images to be interpreted as 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 imaging) where a software error 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 13,297 Allura Xper FD20/15 systems, model number 722058. These are dedicated vascular and neurovascular imaging systems used for diagnostic and interventional procedures, including angiography, stent placements, and cardiac imaging. The recall covers all serial numbers and affects units distributed worldwide, including the United States, Puerto Rico, and numerous international locations.
The recall is being issued because the use of the system regarding live and still images can lead to still images being interpreted as live images. This error may occur on Allura Xper, Allura Clarity, Allura CV, Allura Centron, and UNIQ systems. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
Healthcare facilities and users of these systems should contact Philips Electronics North America Corporation for instructions on how to resolve the issue. The source text does not provide specific consumer action steps beyond the general recall notification.
The recalled product
- Product
- Allura Xper FD20/15; Model Numbers: 722058 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
- 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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