GE Healthcare, LLC Recall 89720
Description: Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
GE Healthcare, LLC Recall 89720 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0857-2022 |
| Event ID | 89720 |
| Event Description | Signa 1.5T TwinSpeed Magnetic Resonance Imaging System |
| Product Type | Devices |
| 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. |
| Quantity | 10 units |
| Recall Reason | There is potential for the images to be flipped left to right. |
| Device Classification | 20220413 |
| Device Code Info | System IDs: MMIMR01, 213748HDMR, 714125MR, 561218MR1, 918523MR1,304766MR1, 082427030026, 082427080007, 082427020017, 376569401MR |
| Center Classification Date | 20220404 |
| Recall Initiation Date | 20220218 |
| Recalling Firm | GE Healthcare, LLC |
| Initial Notification | Letter |
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