PlainRecalls
FDA Devices Critical Class I Terminated

GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System

Reported: November 21, 2018 Initiated: September 14, 2018 #Z-0370-2019

Product Description

GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System

Reason for Recall

A detector can detach and fall.

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
1,166
Distribution
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
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled?
GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System. Recalled by GE Healthcare, LLC. Units affected: 1,166.
Why was this product recalled?
A detector can detach and fall.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 21, 2018. Severity: Critical. Recall number: Z-0370-2019.