Device product
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.
Z-1754-2019
Product summary
- Event
- Event 82668
- Status
- Terminated
- Classification
- Class II
- Quantity
- 825 (38 US and 787 OUS) in total
- Official record key
device-enforcement:Z-1754-2019
Official wording
Reason: There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
Code information: 204787RF1; 205814RF1; 209826500D; 229P500RF2; 410448RF; 417682BRF; 506857P500; 519663PR500; 519685PR500; 561791RM2; 603668C5; 618635RF; 636625SJR1; 718630PRECISION; 770793KP500D2; 810326P500; 850494WF4; 903731PRP500; 985230DCRF4; and AM16KFZ328.
Distribution pattern: 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, French Polynesia, Germany, Greece, Guadeloupe, Guyana, Hungary, Italy, Japan, Korea, Lebanon, Mexico, Morocco, New Caledonia, Norway , Poland, Portugal, Russia, Saudi Arabia,Slovakia, Spain, Taiwan, Tunisia, Turkey, Ukraine, United Kingdom, Venezuela, and Vietnam.
Derived failure modes
-
Unknown
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.