FDA Device recall Z-1921-2020
Philips Brilliance iCT Computed Tomography X-Ray System
- FDA Device
- Class II
- terminated
- Published 2020-05-13
On 2020-05-13 the FDA classified a Class II recall of Philips Brilliance iCT Computed Tomography X-Ray System by Philips North America, citing the bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1921-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-06 |
| Published | 2020-05-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips North America |
| Distribution | IA |
Product
Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848
Reason
The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.
Identifiers
| code_info | Serial #s 100193, 100408, 100457, 100783, 100356, 100113, 100380, 100318, 100848, 100112, 100742, 100447,…Serial #s 100193, 100408, 100457, 100783, 100356, 100113, 100380, 100318, 100848, 100112, 100742, 100447, 100685, 100375, 100449, 100659, 100158, 100398 Additional serial number as of 5/22/20: 100117 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1921-2020%22
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