Recall Z-1055-2024 ยท JAK System, X-Ray, Tomography, Computed
PHILIPS MEDICAL SYSTEMS
Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.
| Date | Feb 8, 2024 (initiated Dec 13, 2023) |
| Status | Open, Classified |
| Reason | A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Medical Device Correction notice (2023-PD-CTAMI-017) dated December 13, 2023 was issued via Certified Mail. Philips Field Service Engineers will contact customers to schedule an onsite visit to install update software correcting the issue. Customers are asked to complete and return the response form and circulate the notice to all users of the device for awareness. Contact Philips Customer Care Solutions Center 1-800-722-9377 with questions. |
| Quantity | US: 33, OUS 177 |
| Distribution | Worldwide - US Nationwide distribution in the states of AR, AZ, GA, HI, IN, KY, MA, MD, MN, NY, OH, PA, TX & WV; the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Germany, Israel, Italy, Japan, Macao, Malaysia, Netherlands, Norway, Palestine, Panama, Portugal, Singapore, |
| 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 |