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GE Healthcare, LLC Recall 89720

Description: Signa 1.5T TwinSpeed Magnetic Resonance Imaging System

GE Healthcare, LLC Recall 89720 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0857-2022
Event ID89720
Event DescriptionSigna 1.5T TwinSpeed Magnetic Resonance Imaging System
Product TypeDevices
DistributionWorldwide Distribution. US nationwide, Argentina, Australia, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, China, Denmark, Ecuador, Ethiopia, France, Germany, Greece, Hong Kong, India, Iran, Ireland, Italy, Japan, Korea, Kuwait, Lebanon, Mexico, Netherlands, New Zealand, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Turkey, United Arab Emirates, and United Kingdom.
Quantity10 units
Recall ReasonThere is potential for the images to be flipped left to right.
Device Classification20220413
Device Code InfoSystem IDs: MMIMR01, 213748HDMR, 714125MR, 561218MR1, 918523MR1,304766MR1, 082427030026, 082427080007, 082427020017, 376569401MR
Center Classification Date20220404
Recall Initiation Date20220218
Recalling FirmGE Healthcare, LLC
Initial Notification Letter
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