Recall Z-0985-2015 ยท JAK System, X-Ray, Tomography, Computed
GE Healthcare
GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.
| Date | Jan 15, 2015 (initiated Dec 19, 2014) |
| Status | Terminated |
| Reason | Potential safety issue due to a required torque check on three bolted joints of the Revolution CT scanner. No injuries or illnesses reported. |
| Root cause | Process control |
| Action | Consignees were sent on 12/19/2014 a GE Healthcare "Urgent Medical Device Correction" letter GEHC # 25457 dated December 19, 2014. The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology / Cardiology and Radiologists / Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (US phone 800-437-1171, Japan 0120-055-919, other countries contact your local GE Healthcare Service Representative). |
| Quantity | 13 (7 US, 6 OUS) |
| Distribution | US: FL, WA, IL, UT, NY, CA. OUS: Canada, France, Hong Kong, Japan, Switzerland, United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133705 | REVOLUTION CT Ge Medical Systems, LLC, Apr 11, 2014 |