Drug recall
Brilliance iCT - Model 728306 Computed Tomography X-ray systems
FDA recall event 78830 · Class II · Philips Medical Systems (Cleveland) Inc
Key facts
| Event ID | 78830 |
|---|---|
| Recall numbers | Z-0402-2018, Z-0403-2018 |
| Recalling firm | Philips Medical Systems (Cleveland) Inc |
| Product type | Devices |
| Products | Brilliance iCT - Model 728306 Computed Tomography X-ray systems, Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of… |
| Initiation date | Jul 11, 2017 |
| Report date | Jan 31, 2018 |
| Termination date | Jul 2, 2019 |
| 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: