Recall Z-1101-2021 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
GE Healthcare, LLC
GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended for use by a qualified/trained doctor or technologist on both adult and pediatric subjects taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities and other body parts.
| Date | Dec 10, 2020 |
| Status | Terminated |
| Reason | GE Healthcare has become aware of a potential safety issue associated with the improper installation of the Precision 600FP monitor suspension. A partial detachment of the monitor suspension could result in potential injury to a patient or operator. |
| Root cause | Other |
| Action | The firm issued an urgent medical device correction notice by letter on 12/10/2020. The letter states: "You can continue to use your Precision 600 FP monitor suspension under the following condition. If you observe any abnormal movement or misalignment of the monitor suspension in day to day performance controls, discontinue use and contact your GE Healthcare Service Representative immediately." Customers with questions or concerns may contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. |
| Quantity | 113 units |
| Distribution | US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NJ, NM, NV, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, WV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133553 | KALARE Toshiba America Medical Systems, In.C, Jun 13, 2014 |