Recall Z-1318-2026 ยท JAK System, X-Ray, Tomography, Computed
Philips North America Llc
Spectral CT 7500 on Rails; Product Code (REF): 728334;
| Date | Feb 6, 2026 (initiated Jan 7, 2026) |
| Status | Open, Classified |
| Reason | As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled. |
| Root cause | Process change control |
| Action | On or about January 7, 2026 URGENT Medical Device Correction letters were sent to customers. Actions to be taken: 1. As a precaution, monitor the gantry for any unusual sounds or vibrations during operation. If unusual sounds are heard or vibrations are observed, immediately call your service contact. In the absence of unusual sounds or vibrations, you may continue to use your system(s) according to the intended use. 2. Circulate this Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue. Please retain this letter with your system(s) until Phil |
| Quantity | 3 units |
| Distribution | Worldwide - US Nationwide distribution in the states of AL, AR, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MD, MN, NC, NY, OH, OR, PA, TX, VT, WA, WV and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egy |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212875 | Spectral CT on Rails Philips Medical Systems Nederland B.V., May 13, 2022 |