Recall Z-0762-2020 ยท LNH System, Nuclear Magnetic Resonance Imaging
Deerfield Imaging, Inc.
iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite with integrated MRI and X-ray angiography. The IMRIS iMRX system is the integration of a Siemens Artis zee family (biplane or floor or ceiling mounted single plane) and the IMRIS Neuro 3T System. The System is a solution providing MRI scanning capabilities in the angiography room while retaining
| Date | Nov 26, 2019 |
| Status | Terminated |
| Reason | There is a potential hardware error for the iMRX System with a generator A100. A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible |
| Root cause | Component design/selection |
| Action | An Urgent Field Safety Notice letter was sent to customers on 11/26/2019 via FedEx.. The letter state the issue, potential risk, the actions to be taken, and stated that the device will be modified. Questions can be directed to the service line at 1-866-475-0525. |
| Quantity | 6 |
| Distribution | CT, MA, VA. International distribution: Australia, Canada, and Qatar. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101813 | IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO Imris, Inc., Oct 5, 2010 |