Drug recall
Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit per package Product Usage…
FDA recall event 69969 · Class II · Philips Medical Systems (Cleveland) Inc
Key facts
| Event ID | 69969 |
|---|---|
| Recall numbers | Z-0979-2015 |
| Recalling firm | Philips Medical Systems (Cleveland) Inc |
| Product type | Devices |
| Products | Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit per package Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion. |
| Initiation date | Dec 8, 2014 |
| Report date | Jan 21, 2015 |
| Termination date | Oct 1, 2015 |
| 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: