Philips INTEGRIS and Allura Systems Recalled for Image Display Error
Philips is recalling INTEGRIS and Allura 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 involves a risk-of-harm product (medical device) where a software error could lead to misinterpretation of images, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Philips Electronics North America Corporation is recalling the INTEGRIS H3000 (Model 72238) and various Allura systems, including Allura Xper, Allura Clarity, Allura CV, and Allura Centron. The recall involves 13,297 units distributed worldwide, including the United States and Puerto Rico.
The recall is due to a software issue where the use of live and still images can lead to still images being interpreted as live images. This error could affect the interpretation of diagnostic and interventional procedures.
Healthcare facilities and users should contact Philips for instructions on how to resolve the issue. The recall covers all serial numbers for the affected models.
The recalled product
- Product
- INTEGRIS H3000; Model Number: 72238 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional…
- 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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