Recall Z-0876-2020 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Healthcare, LLC
SIGNA Pioneer Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
| Date | Jan 28, 2020 (initiated Dec 23, 2019) |
| Status | Terminated |
| Reason | It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system's date and time setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images. |
| Root cause | Software design |
| Action | This issue will be resolved by sending an Urgent Medical Device Correction letter to Medical Facility staff (Director of Clinical/Radiology, Risk Manager/Hospital Administrator, Director of Biomedical Engineering) with affected systems. This letter will inform the customer of the issue and instruct the user to ensure the displayed system date is correct. The long-term solution is to correct affected systems with updated software. |
| Quantity | 62 (30 US, 32 OUS) total devices |
| Distribution | Worldwide distribution - US nationwide distribution and countries of Australia, China, France, Germany, India, Italy, Japan, Netherlands, Oman, Spain, Sweden, Switzerland, Turkey, and United Kingdom. |
| FDA record | Open on fda.gov |