Philips UNIQ and Allura Systems Recall for Image Interpretation Error
Philips is recalling UNIQ and Allura systems because a software issue may cause still images to be misinterpreted as live images during medical 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 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 the UNIQ FD OR table (Model Number 722035) and Allura Xper, Allura Clarity, Allura CV, and Allura Centron systems. The recall involves 13,297 units distributed worldwide, including the United States, Puerto Rico, and numerous international markets.
The recall is due to a software defect where the use of these systems regarding live images and still images can lead to still images being interpreted as live images. This error could affect the interpretation of diagnostic, interventional, and minimally invasive procedures, including vascular, cardiovascular, and neurovascular imaging applications.
Healthcare facilities and users of these systems should contact Philips for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- UNIQ FD OR table; Model Number 722035 The Philips UNIQ is intended for use on human patients to perform: " Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral…
- 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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