Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System

FDA Recall Z-0369-2019 · Posted 2018-11-14

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeKPS
Date Initiated2018-09-14
Date Terminated2020-10-08
Product Quantity276

Reason for Recall

A detector can detach and fall.

Firm Action

GE Healthcare will inspect and if required correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the inspection.

Root Cause

Other

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K962738MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMSGE Medical Systems · 1996-10-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑