Philips Recalls Allura Xper FD20 Biplane Systems Due to Image Display Error
Philips is recalling Allura Xper FD20 Biplane systems because a software issue may cause still images to be misinterpreted as live images.
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 is classified as FDA Class II, and the hazard involves a risk of harm (misinterpretation of medical images) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Philips Electronics North America Corporation is recalling 13,297 units of the Allura Xper FD20 Biplane system, including model numbers 722013, 722008, and 722015. These medical devices are used for dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures such as angiography, stent placements, and pacemaker implantations.
The recall was initiated because the use of these systems regarding live and still images can lead to still images being interpreted as live images. This error could potentially impact the interpretation of medical imaging data during procedures.
The affected units were distributed worldwide, including the United States (nationwide), Puerto Rico, and numerous international countries. The recall applies to all serial numbers of the specified models. Healthcare providers and consumers should contact Philips for further instructions on how to address this issue.
The recalled product
- Product
- Allura Xper FD20 Biplane; Model Numbers: 722013 722008 722015 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…
- Manufacturer
- Philips Electronics North America Corporation
- 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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