Precision 500D The Precision 500D R&F X-ray System is recall
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…
Why was Precision 500D The Precision 500D R&F X-ray System is recalled?
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
204787RF1; 205814RF1; 209826500D; 229P500RF2; 410448RF; 417682BRF; 506857P500; 519663PR500; 519685PR500; 561791RM2; 603668C5; 618635RF; 636625SJR1; 718630PRECISION; 770793KP500D2; 810326P500; 850494WF4; 903731PRP500; 985230DCRF4; and AM16KFZ328.
- 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…
- Recalling firm
- GE Healthcare, LLC
- 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, 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.
- Recall date
- June 19, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)