Philips North America, LLC recalls Azurion FlexArm, 722079
- Recall date
- March 12, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1130-2019
- FDA classification
- Class II
- Brand / firm
- Philips North America, LLC
- Sold / distributed
- Distributed to one account in Florida, and one international account in Germany.
Why it was recalled
During manufacturing of an Azurion R2.0 system, it was found out that the cable set was not according to specification. This resulted in damage of the 24V power cable of the detector.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Azurion FlexArm, 722079
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