Philips Allura Xper X-Ray Angiographic Software Recall
Philips Medical Systems is recalling Allura Xper X-Ray Angiographic systems due to a software error that may prevent the five-minute fluoroscopy audible signal from sounding.
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 failure of a safety signal (audible alarm) during a medical procedure, which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Philips Medical Systems, Inc. is recalling 7,439 units of the Allura Xper X-Ray Angiographic system. The recall is due to a software error that, in certain circumstances, can lead to a situation where the five-minute fluoroscopy audible signal does not sound.
The affected software releases include PBL 10, 20, 30, 40, 50, and 60; CV20; R7.2x; R7.6; R8.1; and R8.2. The products were distributed worldwide, including the United States (nationwide including Puerto Rico) and numerous other countries.
This is a Class II recall, which means the product may cause temporary or medically reversible health consequences. Users should contact Philips Medical Systems for further instructions on how to address the software issue.
The recalled product
- Product
- Philips Medical System Allura Xper X-Ray Angiographic
- Manufacturer
- Philips Medical Systems, Inc.
- Affected units
- 7,439
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 (11)
- Software releases: PBL 10
- 20
- 30
- 40
- 50
- and 60
- CV20
- R7.2x
- R7.6
- R8.1
- and R8.2.
Distribution
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