Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1130-2019 — Azurion FlexArm, 722079

U.S. FDA — Device Enforcement · United States · 2019-03-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1130-2019
Date of alert
2019-03-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips North America, LLC
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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