Philips Allura Xper System power supplies may fail unexpectedly
Certain low-voltage power supplies in Philips Allura Xper interventional X-ray systems may fail, potentially causing loss of imaging functionality. 42 devices are affected worldwide.
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: FDA Class II medical device where power supply failure could cause sudden loss of imaging functionality or mechanical movement during clinical procedures. This is a risk-of-harm product where potential injury has not yet been reported, meeting the High category criterion.
Plain-English summary
Philips Medical Systems Nederlands is recalling 42 Allura Xper interventional fluoroscopic X-ray systems due to a potential failure in certain low-voltage DC power supplies (DCPS).
Failure of a power supply may result in the sudden loss of imaging functionality or mechanical movement, depending on which subsystems the power supply is powering.
The affected systems (Product Nos. 722026, 722027, 722028, 722029, 722035, 722038, and 722058) were distributed from September 16, 2014 through May 4, 2016. Affected locations include the United States (Alabama, Arizona, Florida, Georgia, Illinois, Massachusetts, Missouri, New Jersey, Oregon, and Virginia), Netherlands, United Kingdom, Poland, Spain, France, Czech Republic, India, Brazil, Singapore, Japan, Colombia, United Arab Emirates, China, Russian Federation, Oman, and Mexico.
The recalled product
- Product
- Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058.
- Manufacturer
- Philips Medical Systems Nederlands
- Category
- Medical Device
- Affected units
- 42
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 (6)
- Product No.: 722026
- 722027
- 722028
- 722029
- 722035
- 722038
Distribution
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