FDA-Device2019-04-17Class II
Azurion FlexArm, 722079
Philips North America, LLC
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.
Sold states
Distributed to one account in Florida, and one international account in Germany.
Affected count
2
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
Azurion FlexArm, 722079
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1130-2019Don't want to check this manually?
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