Drug recall
Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body.
FDA recall event 74511 · Class II · Philips Medical Systems (Cleveland) Inc
Key facts
| Event ID | 74511 |
|---|---|
| Recall numbers | Z-2111-2016, Z-2112-2016, Z-2113-2016, Z-2114-2016, Z-2115-2016 |
| Recalling firm | Philips Medical Systems (Cleveland) Inc |
| Product type | Devices |
| Products | Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body., Brilliance iCT model #728306; Intended to produce cross- sectional images of the body., Ingenuity Core 128, model #728323; Intended to produce cross- sectional images of the body., Ingenuity Core, model # 728326; Intended to produce cross- sectional images of the body., Ingenuity Flex, model # 728317; Intended to produce cross- sectional images of the body. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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., 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…, Supplier design change contributed to a thinner… |
| Initiation date | Jun 21, 2016 |
| Report date | Jul 6, 2016 |
| Termination date | Jul 2, 2018 |
| City | Cleveland |
| State | OH |
| Country | United States |
| FEI number | 1525965 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: