Z-1923-2020 Class II Terminated
FDA device recall Z-1923-2020 was initiated by Philips North America, LLC on April 6, 2020 and is designated Class II. Reason for recall: The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems. The recall status is terminated (terminated September 16, 2022). Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2020
- Initiation Date
- April 6, 2020
- Termination Date
- September 16, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI # (01)00884838059542(21)860067
Reason for Recall
The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.
Distribution Pattern
Worldwide distribution including one unit distributed to Iowa.
Code Information
Serial #s 860067, 860023