Z-1754-2019 Class II Terminated
FDA device recall Z-1754-2019 was initiated by GE Healthcare, LLC on March 29, 2019 and is designated Class II. Reason for recall: There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging. The recall status is terminated (terminated April 15, 2021). Affected quantity: 825 (38 US and 787 OUS) in total.
Recall Details
- Product Type
- Devices
- Report Date
- June 19, 2019
- Initiation Date
- March 29, 2019
- Termination Date
- April 15, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 825 (38 US and 787 OUS) in total
Product Description
Reason for Recall
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.