Drug recall
Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model…
FDA recall event 94536 · Class II · Philips North America Llc
Key facts
| Event ID | 94536 |
|---|---|
| Recall numbers | Z-1871-2024, Z-1872-2024 |
| Recalling firm | Philips North America Llc |
| Product type | Devices |
| Products | Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728143, Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728144 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located… |
| Initiation date | Apr 15, 2024 |
| Report date | May 29, 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: