FDA recall Z-1130-2019

Philips North America, LLC · Class II · device

Product

Azurion FlexArm, 722079

Reason for recall

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.

Distribution

Distributed to one account in Florida, and one international account in Germany.

Key facts

Status: Terminated
Initiation date: 2019-03-12
Report date: 2019-04-17
Termination date: 2020-10-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1130-2019