Recall Z-1754-2019 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
GE Healthcare, LLC
Precision 500D The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations.
| Date | Jun 10, 2019 (initiated Mar 29, 2019) |
| Status | Terminated |
| Reason | There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging. |
| Root cause | Device Design |
| Action | On March 29, 2019, GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated March 29, 2019 to its consignees/customers. The letter described the product, problem and actions to be taken. Customers were instructed to do the following: Please follow the precautions below until the monitor feet on your unit are replaced: -The CRT monitor and suspension should be inspected and used with caution. Make sure the monitors are secured properly to the tray before each use. -Immediately stop using the system if any looseness of the monitor is noticed and contact your GE service represent |
| Quantity | 825 (38 US and 787 OUS) in total |
| Distribution | Worldwide Distribution: US (nationwide) to states of: AL, CA, CT, FL, GA, HI, IL, LA, MD, MI, MN, MO, NH, NY, OK, PA, TN, and VA; and countries of: Algeria, Argentina, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Canada, China, Costa Rica, Cote D'Ivoire, Cyprus, Czech Republic, Egypt , France, F |
| FDA record | Open on fda.gov |