FDA Device recall Z-2111-2016
Brilliance CT Big Bore Oncology, model #728243
- FDA Device
- Class II
- terminated
- Published 2016-07-06
On 2016-07-06 the FDA classified a Class II recall of Brilliance CT Big Bore Oncology, model #728243 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 and cause injury to patients, opera….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2111-2016 |
| 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 CT Big Bore Oncology, model #728243; 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 and cause injury to patients, operators, by standers or service personnel.
Identifiers
| code_info | 921216 |
|---|
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-2111-2016%22
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