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GE Healthcare, LLC Recall 88665

Description: SIGNA Pioneer nuclear magnetic resonance imaging system

GE Healthcare, LLC Recall 88665 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0134-2022
Event ID88665
Event DescriptionSIGNA Pioneer nuclear magnetic resonance imaging system
Product TypeDevices
DistributionDistribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, TX, VA, WA, and Puerto Rico OUS distribution to: Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, UAE, and UK
Quantity5 devices
Recall ReasonUnder certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Device Classification20211027
Device Code InfoSoftware version PX29.1; and PX25.4 (T), PX28.3 (China only)
Center Classification Date20211016
Recall Initiation Date20210826
Recalling FirmGE Healthcare, LLC
Initial Notification Letter
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