Recalls / —
—#192297
Product
Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
- FDA product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K012200
- Affected lot / code info
- System IDs: MMIMR01, 213748HDMR, 714125MR, 561218MR1, 918523MR1,304766MR1, 082427030026, 082427080007, 082427020017, 376569401MR
Why it was recalled
There is potential for the images to be flipped left to right.
Root cause (FDA determination)
Device Design
Action the firm took
This issue will be resolved by sending an Urgent Medical Device Correction letter to customers with affected systems. This 2/18/2022 letter informs the customer of the issue and provides actions to be taken for the continued use of the device. GE Healthcare will provide a revised service manual that includes a required Finalization step that ensures a geometry check with a DQA phantom (or similar) following Gradient Switch servicing to ensure cable placement is correct and will have no impact on image orientation. A second letter was send to customers on 07/27/2022 and included instructions and link for customer to access and download the revised service manual.
Recalling firm
- Firm
- GE Healthcare, LLC
- Address
- 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615
Distribution
- Distribution pattern
- 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.
Timeline
- Recall initiated
- 2022-02-18
- Posted by FDA
- 2022-04-04
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #192297. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.