Drug recall
Brilliance Big Bore Radiology 728244
FDA recall event 80176 · Class II · Philips Medical Systems (Cleveland) Inc
Key facts
| Event ID | 80176 |
|---|---|
| Recall numbers | Z-2273-2018, Z-2274-2018, Z-2275-2018, Z-2276-2018, Z-2277-2018 |
| Recalling firm | Philips Medical Systems (Cleveland) Inc |
| Product type | Devices |
| Products | Brilliance Big Bore Radiology 728244, Ingenuity Core128 728323, Ingenuity Core128/Elite China 728324, Ingenuity TF PET/CT 882442, Philips Ingenuity Core 728321 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or… |
| Initiation date | Mar 28, 2018 |
| Report date | Jul 4, 2018 |
| Termination date | Apr 21, 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: