Recall Z-2214-2011 ยท JAK System, X-Ray, Tomography, Computed
GE Healthcare, LLC
BrightSpeed Excel Select, BrightSpeed Edge Select ,BrightSpeed Elite Select and BrightSpeed Elite Computed Tomography X-ray systems with software version 09BW35.11 or 09HW30.4. The GE BrightSpeed Delight Series Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, for p
| Date | May 19, 2011 (initiated Jan 19, 2011) |
| Status | Terminated |
| Reason | GE Healthcare has become aware of a potential set of circumstances that could cause X-ray continuation during an unexpected table stop on certain BrightSpeed systems (BrightSpeed Excel/Edge/Elite Select and BrightSpeed Elite Computed Tomography X-ray Systems ) if this event were to occur on your system, patient safety may be impacted. |
| Root cause | Software design |
| Action | The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION GE Ref: 22932" letter dated January 19, 2011 to its consignees/customers. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction, Contact Information, and Additional Dosimetric Information. A second letter dated March 11, 2011 was sent to the consignee/customer letter consisting of a cover letter and an attachment. "This letter is to notify you of an error in the January 19, 2011, Urgent Medical Device Correction Letter, that you have already received (GE Ref: 22932). In the |
| Quantity | 479 |
| Distribution | Worldwide distribution: USA (nationwide) including states: AL, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, OH, PR, RI, SC, SD, TN, TX, and WV; and countries including: URUGUAY, TURKEY, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SAUDI ARABIA, RUSSIAN FEDERAT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082816 | GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM Ge Medical Systems, LLC, Oct 8, 2008 |