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FDA (Device enforcement)Recalled 2018-09-14closedclass i

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

Is my product affected?

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

  • UPC 082426100010
  • UPC 082426010005
  • UPC 082426030006
  • UPC 82426200006
  • UPC 82426100014
  • UPC 82426100004
  • UPC 82426190009
  • UPC 82426100022
  • UPC 82426020003
  • UPC 82426020004
  • UPC 82426310018
  • UPC 82426060002
  • UPC 82426110005
  • UPC 82426080013
  • UPC 82426170002
  • UPC 82426040040
  • UPC 82426080015
  • UPC 82426050006
  • UPC 82426130028
  • UPC 82426080017
  • UPC 82426100039
  • UPC 82426070026
  • UPC 82426210018
  • UPC 83026843025441
  • UPC 83026102101026
  • UPC 83026002100286
  • UPC 08302603017002
  • UPC 83026602100758
  • UPC 83026042100775
  • UPC 83026042101847
  • UPC 83026802101537
  • UPC 83026842100997
  • UPC 83026841019810
  • UPC 83026002101937

Check against the official notice below — it lists the full affected range.

What happened

GE Healthcare is recalling 1,166 GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition Systems because a detector can detach and fall. The affected systems have been distributed throughout the United States, including all 50 states, the District of Columbia, Guam, and Puerto Rico, as well as internationally to countries including Canada, Australia, China, India, and many others.

The recall affects systems with specific identification numbers listed in the distribution record. The source document does not specify what remedy is available to consumers who own or operate these affected systems.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

A detector can detach and fall.

Details from the source

Reason for recall: A detector can detach and fall. 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, Jamai Quantity: 1,166 Lot/code info: System ID #: 334428MG, 256235NM2, 251660KWMG, 251410IMCMG, 501776MG, 870836MG, 870364MG, 479443MG1, 870261MG, 501520MG, 501614MC, 501224MC, 501686MG, 501202WMG, 870541MG, 501380MG, 479751MG, 501484MG, 479314MG2, 501474MG, 480393MG, 928758NM, 480425NM1, 602588NM2, 520GVHMG, 480830NM1, 928699MG, 602251NM2, 602588NM3,623478NM1, 480820NM1, 602392NM2, 623933NM1, 602870NM2, 623879NM1, 602964MG1, 480838MG, 480844NM1, 714456MG, 661663MG1, RADNETNM170, 661322MG, 909390MG, 707464NUC, 714979MG, 510792MG, 916537MG, 5668, 1572, 951698MG1, RADNETNM1732, 949863MG, 818885MG, 805988MG, RADNETNM1726, 626397MG, 30244MVC, 209835MG, 916781MG1, 415600DAVMG, 831759MG1, 831759MG2, 619287MG, 707576MG1, 408278MG1, 707546MG, 209944MC1, RADNETNM175, 310543MG, 310214MG, 707463MG, 818782MG, RADNETNM171, 626814MG, 530741MG, 30337NM, 719275MG, 719475MG, 970565MG, 303398MG, 303629MG, 303715MC1, 303715MC, 303673MG1, 303426MG1, 203797NM5, 203797NM7, 203797NM6, 203797NM4, 860364MILL, 860496MILL, 203238NM, 202529MC, 407303FAMC1, FHALTMG2, 407SMALMG, 407303FAMG1, FHAPMG, 561642MG1, 561642MG2, 561642MG3, 561742MG1, 813571MG, 718444MG1, 718444MG1, 239432MG, 727461MG, 727446MG, 305446MG, 305461MG, 352564XEL1, 863419MG2, 305529MG, 941473MG, 239938MG, 561468MG1, 850863MILMG, 352333MG, 352331MG, 305820MG, 305826MG, 904389MG, 904202OPMG, 407518MG, 07SMKSMG, 561795MGLW, 863680MG, 863687MG, 941368MG, 561791MG1, 321725MG3, 321725MG2, 305596B84, 305279MG, 305512EXL, 305821MG, 941436MG1, 850678TCMG, 352401WMMG, 352401MC, 352

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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