Z-1774-2021 Class II Terminated
FDA device recall Z-1774-2021 was initiated by Philips North America Llc on April 13, 2021 and is designated Class II. Reason for recall: Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury The recall status is terminated (terminated September 23, 2022). Affected quantity: 2 units (1 US and 1 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- June 9, 2021
- Initiation Date
- April 13, 2021
- Termination Date
- September 23, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units (1 US and 1 OUS)
Product Description
BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
Reason for Recall
Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the state of NV and the country of Japan.
Code Information
Serial Numbers: 100100, 100434