Brilliance CT Big Bore Oncology — Class II medical device recall Z-2111-2016
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2016-07-06. Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. Th
| Recall number | Z-2111-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland) Inc, Cleveland, OH, United States |
| Recall initiated | 2016-06-21 |
| Classified | 2016-06-30 |
| Reported by FDA | 2016-07-06 |
| Terminated | 2018-07-02 |
| Countries outside the US | CH, CN, DE, DK, ES, GB, HU, IT, PH, SE, TH |
| Quantity | 3 units |
| Reason classes | packaging |
| Model numbers | 728243 |
Product
Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2111-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.