Drug recall
Spectral CT. Computed tomography X-ray system.
FDA recall event 97010 · Class II · Philips North America Llc
Key facts
| Event ID | 97010 |
|---|---|
| Recall numbers | Z-2034-2025 |
| Recalling firm | Philips North America Llc |
| Product type | Devices |
| Products | Spectral CT. Computed tomography X-ray system. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that… |
| Initiation date | May 29, 2025 |
| Report date | Jul 2, 2025 |
| 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: