Recall Z-1130-2021 ยท JAK System, X-Ray, Tomography, Computed
GE Healthcare, LLC
System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.
| Date | Dec 17, 2020 |
| Status | Terminated |
| Reason | GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the table pinch protector could be damaged or missing leading to exposed table screws which could cause a laceration due to a sharp edge. |
| Root cause | Process change control |
| Action | The manufacturer sent an "Urgent Medical Device Correction" letter (GEHC Ref# 25496) to customers with affected systems on 12/17/2020. |
| Quantity | 1115 units |
| Distribution | Worldwide - US Nationwide Distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NV, NY, NH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV; In the countries of Algeria, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brazi |
| FDA record | Open on fda.gov |