Philips Allura Xper and UNIZ Systems Recalled for Monitor Freezing
Philips is recalling 682 Allura Xper and UNIZ interventional fluoroscopic x-ray systems because the large screen monitor may freeze for 15 seconds after continuous operation.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a temporary software glitch (15-second freeze) with no reported injuries, deaths, or significant property damage, fitting the criteria for a moderate risk or voluntary precautionary recall.
Plain-English summary
Philips Electronics North America Corporation is recalling 682 units of the Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor). These are interventional fluoroscopic x-ray systems intended for use on human patients to perform vascular, cardiovascular, and neurovascular imaging applications, including diagnostic, interventional, and minimally invasive procedures.
The recall is due to a defect where, after continuous operation for more than one and a half days, the image on the large screen monitor may freeze for approximately 15 seconds. The system will restore itself after the freeze. The affected products were distributed worldwide to numerous countries and to specific US states.
Healthcare facilities should contact Philips to arrange for a software update or repair to resolve the issue. Patients and providers should be aware that the temporary freeze may interrupt the display of imaging data during procedures.
The recalled product
- Product
- Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system Product Usage: The Allura Xper ED series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging…
- Manufacturer
- Philips Electronics North America Corporation
- Affected units
- 682
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 (20)
- 722005
- 722006
- 722008
- 722010
- 722011
- 722012
- 722013
- 722014
- 722015
- 722019
- 722020
- 722022
- 722023
- 722024
- 722025
- 722026
- 722027
- 722028
- 722029
- 722033
Distribution
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