Drug recall
The Oncology Essentials Package of the Spectral CT imaging system.
FDA recall event 94352 · Class II · Philips North America Llc
Key facts
| Event ID | 94352 |
|---|---|
| Recall numbers | Z-1756-2024 |
| Recalling firm | Philips North America Llc |
| Product type | Devices |
| Products | The Oncology Essentials Package of the Spectral CT imaging system. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subsequent incorrect treatment. |
| Initiation date | Mar 29, 2024 |
| Report date | May 8, 2024 |
| City | Cambridge |
| State | MA |
| Country | United States |
| FEI number | 3016618143 |
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: