Z-0371-2019 Class I Terminated
FDA device recall Z-0371-2019 was initiated by GE Healthcare, LLC on September 14, 2018 and is designated Class I. Reason for recall: A detector can detach and fall. The recall status is terminated (terminated October 8, 2020). Affected quantity: 18.
Recall Details
- Product Type
- Devices
- Report Date
- November 21, 2018
- Initiation Date
- September 14, 2018
- Termination Date
- October 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18
Product Description
Reason for Recall
Distribution Pattern
United States: AK,AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,Guam,MA,MD,ME,MI,MO,MS,MT,NC,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,PR, RI,SC,SD,TN,TX,UT,VA,VT,WA,WI AND WV International: Albania, Argentina, Australia, Azerbaijan, Belgium, Bosnia ,Herzegovina, Brazil, Canada, Chile, China, Costa Rica, Colombia, Cyprus, France, Germany, Greece, Guatemala, Honduras, Iceland, India, Iraq, Italy, Jamaica, Japan, Kenya, Korea, Macedonia, Mexico, Namibia, Panama, Peru, Philippines, Portugal, Russia, South Africa, Spain Switzerland, Taiwan, United Kingdom, Turkey, Venezuela and Vietnam