Drug recall
Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)
FDA recall event 92238 · Class II · PHILIPS HEADQUARTERS CAMBRIDGE
Key facts
| Event ID | 92238 |
|---|---|
| Recall numbers | Z-1622-2023, Z-1623-2023, Z-1624-2023, Z-1625-2023 |
| Recalling firm | PHILIPS HEADQUARTERS CAMBRIDGE |
| Product type | Devices |
| Products | Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS), Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS), Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS), Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is… |
| Initiation date | Apr 12, 2023 |
| Report date | May 31, 2023 |
| City | Cambridge |
| State | MA |
| Country | United States |
| FEI number | 3016952894 |
At a glance
- 1–9 Products in this recall
- None 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: