Drug recall
Philips Healthcare Brilliance iCT computed tomography x-ray system
FDA recall event 78879 · Class II · Philips Medical Systems (Cleveland) Inc
Key facts
| Event ID | 78879 |
|---|---|
| Recall numbers | Z-0331-2018, Z-0332-2018, Z-0333-2018 |
| Recalling firm | Philips Medical Systems (Cleveland) Inc |
| Product type | Devices |
| Products | Philips Healthcare Brilliance iCT computed tomography x-ray system, Philips Healthcare Brilliance iCT SP computed tomography x-ray system, Philips Healthcare IQon Spectral CT computed tomography x-ray system |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a… |
| Initiation date | Nov 8, 2017 |
| Report date | Jan 17, 2018 |
| Termination date | Apr 17, 2020 |
| 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: