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Philips Healthcare Recall 89023

Description: CombiDiagnost R90 is multi-functional general R/F systems.

Philips Healthcare Recall 89023 Information

StatusOngoing
Mandated?FDA Mandated
Recall NumberZ-0241-2022
Event ID89023
Event DescriptionCombiDiagnost R90 is multi-functional general R/F systems.
Product TypeDevices
DistributionUS Nationwide Distribution
Quantity281 in total
Recall ReasonThe Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 1020.30 (j)] and the X-ray control certification statement [21 CFR 1010.2]. Philips has determined that some systems at customer locations did not have these labels applied.
Device Classification20211201
Device Code InfoCombiDiagnost R90
Center Classification Date20211124
Recall Initiation Date20210922
Recalling FirmPhilips Healthcare
Initial Notification Letter
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