Recall Z-0725-2024 ยท JAK System, X-Ray, Tomography, Computed
Philips North America Llc
Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
| Date | Jan 12, 2024 (initiated Nov 30, 2023) |
| Status | Open, Classified |
| Reason | Multiple software issues that affect device functionality. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 197 units |
| Distribution | Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, China, Czech Republic, Denmark, France, Germany, Israel, Italy, Japan, Malaysia, Netherlands, Norway, Panama, Palestine, Portugal, South Korea, Spain, Switzerland, Thailand, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203020 | Spectral CT Philips Medical Systems Nederland B.V., Feb 26, 2021 |