FDAFDA · Food and drugs·Recall number Z-0857-2022
Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
Published April 13, 2022 · Recall initiated: February 18, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is potential for the images to be flipped left to right.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- Worldwide 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.
- Lot
- System IDs: MMIMR01, 213748HDMR, 714125MR, 561218MR1, 918523MR1,304766MR1, 082427030026, 082427080007, 082427020017, 376569401MR
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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