Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
FDA device recall Z-0725-2024 · posted 2024-01-12 · Open, Classified
Recall details
- Recalling firm
- Philips North America Llc
- Reason for recall
- Multiple software issues that affect device functionality.
- Action taken
- The recalling firm mailed consignees URGENT Medical Device Correction notifications dated 11/30/23. Consignees are asked to identify affected devices by their UDI-DI, of which affected devices are identified as having a UDI-DI of either 00884838101111 or 00884838111103, and a Product Code of either 728333 or 728340. Consignees may continue to use affected devices until a permanent solution is installed utilizing the precautions outlined in Table 2 of the notice. Consignees are asked to complete and return the provided response form no later than 30 days from receipt of the recall notification. Additionally, the recall notification is to be circulated among all users, so they are aware of the software issues. Philips will contact consignees to schedule a time for a field service engineer to visit your site and install the solution. Consignees with any questions or concerns are to contact Philips Customer Care Solutions Center at 1-800-722-9377.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- JAK
- Quantity affected
- 197 units
- Distribution
- Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, China, Czech Republic, Denmark, France, Germany, Israel, Italy, Japan, Malaysia, Netherlands, Norway, Panama, Palestine, Portug
- Date initiated
- 2023-11-30
- Date posted
- 2024-01-12
- Location
- Cambridge, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Spectral CT (K203020) | Philips Medical Systems Nederland B.V. | 2021-02-26 |