Recalls / —

—#168665

Product

GE Healthcare Millennium MC

FDA product code

KPS — System, Tomography, Computed, Emission

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K962738

Affected lot / code info

System ID #: 870735MG, 928333WMM02, 970635MYO, 203576DNT, 407896FMG2, 954634MG, 316267KCN, 601883NMC2, 910483XEL1, 910296MMG, 908277XL2, 908277MG2, 908218MYO, 918496EN1, 972759CROWNMG, 940566MG, 972434MC,and 972473MYO.

Why it was recalled

A detector can detach and fall.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

GE Healthcare, LLC

Address

3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

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

Timeline

Recall initiated

2018-09-14

Posted by FDA

2018-11-14

Terminated

2020-10-08

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #168665. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.