Drug recall
Brilliance CT 10 Air. Computed Tomography X-ray systems intended to produce cross-sectional images of the body…
FDA recall event 71177 · Class II · Philips Medical Systems (Cleveland) Inc
Key facts
| Event ID | 71177 |
|---|---|
| Recall numbers | Z-1647-2015, Z-1648-2015, Z-1649-2015, Z-1650-2015, Z-1651-2015, Z-1652-2015, Z-1653-2015, Z-1654-2015, Z-1655-2015, Z-1656-2015, Z-1657-2015 |
| Recalling firm | Philips Medical Systems (Cleveland) Inc |
| Product type | Devices |
| Products | Brilliance CT 10 Air. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and…, Brilliance CT 16 Air. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and…, Brilliance CT 16 Power. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and…, Brilliance CT 16 Water. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and…, Brilliance CT 40. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. and 6 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so. |
| Initiation date | Mar 16, 2015 |
| Report date | Jun 3, 2015 |
| Termination date | Feb 22, 2017 |
| City | Cleveland |
| State | OH |
| Country | United States |
| FEI number | 1525965 |
At a glance
- 10–99 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: