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Philips North America, LLC recalls Azurion FlexArm, 722079

Recalled April 17, 2019 · FDA recall Z-1130-2019 · Philips North America

Hazard
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. · FDA Class II
Units
2
Sold at
Distributed to one account in Florida, and one international account in Germany.

Description

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.

Product
Azurion FlexArm, 722079
Manufacturer(s)
Philips North America, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov