Recall Z-0401-2016 ยท JAK System, X-Ray, Tomography, Computed
GE Medical Systems, LLC
GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles.
| Date | Oct 23, 2015 |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a potential issue with routine head scans on your Revolution CT scanner. A potential hazardous situation can occur during a routine head scan with possible artifacts that may emulate pathology between the brain tissue and bone in the head images. No injuries have been reported to date related to this issue. |
| Root cause | Software design |
| Action | The firm, GE Healthcare, sent an"Urgent Medical Device Correction" letter GEHC Ref#25465 dated October 23, 2015 to its Consignees. The letter described the Safety Issues, Safety Instructions, Product Correction, Affected Product Details and Contact Information. The consignees were instructed to follow the instructions in existing CT User Manual and the safety instructions listed in the letter. GE will be delivering an addendum to the User Manual that reiterates these mitigations. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-8 |
| Quantity | 125 (US = 37; OUS = 88) |
| Distribution | Worldwide Distribution: US (nationwide) including states of: AL, CA, CT, FL, GA, HI, IL, NY, NC, OH, OR, PA, TX, UT, VA, WA, WI; and countries of: AUSTRALIA, BELGIUM BRAZIL, CANADA, CHINA,DENMARK, FRANCE, GERMANY, HONG KONG, INDONESIA, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, NORWAY, PERU, POLAND, S |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133705 | REVOLUTION CT Ge Medical Systems, LLC, Apr 11, 2014 |