Philips Allura Centron Medical Imaging System Recalled for Image Display Error
Philips is recalling Allura Centron systems because a software error may cause still images to be misinterpreted as live images during medical 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 risk-of-harm product (medical device) where the hazard is a potential 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 Cardiovascular Allura Centron (Model Number: 722400) and other Allura and UNIQ systems. The recall involves 13,297 units distributed worldwide, including the United States and Puerto Rico. The affected systems are intended for use by physicians and trained hospital staff for various cardiovascular and non-vascular imaging and interventional procedures.
The recall is due to a software issue where the use of live images 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.
Healthcare facilities should contact Philips to determine if their systems are affected and to receive instructions for remediation. Patients who have undergone procedures using these systems should consult their healthcare providers if they have concerns about the accuracy of their imaging results.
The recalled product
- Product
- Cardiovascular Allura Centron; Model Number: 722400 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are qualified to perform medical procedures on humans (having a maxi
- 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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