Medical device recalls High risk

GE Healthcare, LLC recalls GE Healthcare Millennium MC

Recall date
September 14, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0371-2019
FDA classification
Class I
Brand / firm
GE Healthcare, LLC
Sold / distributed
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 Ric…

Why it was recalled

A detector can detach and fall.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

GE Healthcare Millennium MC

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