FDA Device recall Z-2112-2016
Brilliance iCT model #728306
- FDA Device
- Class II
- terminated
- Published 2016-07-06
On 2016-07-06 the FDA classified a Class II recall of Brilliance iCT model #728306 by Philips Medical Systems Cleveland, citing supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2112-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-21 |
| Published | 2016-07-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | n/a |
Product
Brilliance iCT model #728306; Intended to produce cross- sectional images of the body.
Reason
Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack.
Identifiers
| code_info | 911162 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2112-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.