Drug recall
MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can be used as a whole body computed…
FDA recall event 69473 · Class II · Philips Medical Systems (Cleveland) Inc
Key facts
| Event ID | 69473 |
|---|---|
| Recall numbers | Z-0190-2015 |
| Recalling firm | Philips Medical Systems (Cleveland) Inc |
| Product type | Devices |
| Products | MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | "The orientation of images is displayed incorrectly. When operator chooses gantry on the right side from operation console, and the patient position is HFDL, HFDR, FFDL or FFDR, the patient… |
| Initiation date | Oct 9, 2014 |
| Report date | Nov 19, 2014 |
| Termination date | Jul 2, 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: