Drug recall
Brilliance 64 Computed Tomography X-ray system
FDA recall event 72684 · Class II · Philips Medical Systems (Cleveland) Inc
Key facts
| Event ID | 72684 |
|---|---|
| Recall numbers | Z-0544-2016, Z-0545-2016, Z-0546-2016, Z-0547-2016, Z-0548-2016, Z-0549-2016 |
| Recalling firm | Philips Medical Systems (Cleveland) Inc |
| Product type | Devices |
| Products | Brilliance 64 Computed Tomography X-ray system, Brilliance iCT Computed Tomography X-ray system, Brilliance iCT SP Computed Tomography X-ray system, Ingenuity Core 128 Computed Tomography X-ray system, Ingenuity Core Computed Tomography X-ray system and 1 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2)… |
| Initiation date | Oct 29, 2015 |
| Report date | Dec 30, 2015 |
| Termination date | Jun 26, 2018 |
| 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: