Recall Z-0583-2025 ยท JAK System, X-Ray, Tomography, Computed
Philips North America Llc
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
| Date | Dec 3, 2024 (initiated Nov 16, 2024) |
| Status | Open, Classified |
| Reason | Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle placed inside the patient, and an incorrect patient ID software issue that may lead to misdiagnosis. |
| Root cause | Under Investigation by firm |
| Action | Philips notified consignees on about 11/16/2024, via certified mail. Consignees were instructed to identify any affected units on hand, identify if those units contain the affected software version, complete and return the response form, and circulate the Urgent Field Safety Notice Letter to all users of the device. To protect the user and patient from the issue of Plan Box not Updated, remain vigilant and confirm table position during procedures. Press any of the Emergency STOP buttons to stop unintended patient table motion and follow safety instructions in Section 6 of the IFU: Working wi |
| Quantity | 301 units |
| Distribution | Worldwide - US Nationwide distribution in the states of AR, AZ, CA, FL, GA, HI, IN, KY, MA, MD, MN, NY, OH, OR, PA, TX, VT, WA, WV and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Ecuador, France, Germany, Hong Kong, Israel, Italy, Japan, Jordan, Macao, Malaysia, Net |
| 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 |