Signa 1.5T TwinSpeed Magnetic Resonance Imaging System recall
Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
Why was Signa 1.5T TwinSpeed Magnetic Resonance Imaging System recalled?
There is potential for the images to be flipped left to right.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
System IDs: MMIMR01, 213748HDMR, 714125MR, 561218MR1, 918523MR1,304766MR1, 082427030026, 082427080007, 082427020017, 376569401MR
- Product
- Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 10 units
- Distribution
- 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.
- Recall date
- April 13, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)