Drug recall
882478: BrightView X designed for single or dual detector nuclear imaging accommodating a range of ECT…
FDA recall event 76483 · Class II · Philips Medical Systems (Cleveland) Inc
Key facts
| Event ID | 76483 |
|---|---|
| Recall numbers | Z-1479-2017, Z-1480-2017, Z-1481-2017 |
| Recalling firm | Philips Medical Systems (Cleveland) Inc |
| Product type | Devices |
| Products | 882478: BrightView X designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body…, 882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body…, 882482: BrightView XCT 882454 BrightView X upgrade to XCT, designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4… |
| Initiation date | Jan 31, 2017 |
| Report date | Mar 22, 2017 |
| Termination date | Jul 2, 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: