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Philips North America Llc Recall 87872

Description: BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306

Philips North America Llc Recall 87872 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1774-2021
Event ID87872
Event DescriptionBRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution in the state of NV and the country of Japan.
Quantity2 units (1 US and 1 OUS)
Recall ReasonCooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury
Device Classification20210609
Device Code InfoSerial Numbers: 100100, 100434
Center Classification Date20210602
Recall Initiation Date20210413
Recalling FirmPhilips North America Llc
Initial Notification Telephone
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