Recall Z-2345-2019 ยท LNH System, Nuclear Magnetic Resonance Imaging
Siemens Medical Solutions USA, Inc
MAGNETOM Prisma magnetic resonance diagnostic devices Model #10849582
| Date | Jul 9, 2019 |
| Status | Terminated |
| Reason | Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly. |
| Root cause | Device Design |
| Action | 1. review the System Owner Manual chapter 1.3.3 Quench emergency plan and the section regarding defective vent line. 2. follow the standard emergency procedures you have in place in the event of system failures. 3.A Siemens Service Technician will conduct an inspection to verify that your system has a vertical outlet. If a vertical outlet is present, no further action is required. In the event your system is equipped with a horizontal outlet, the Siemens Service Technician will ensure that the port for the drop-off plate is adequately blanked off or sealed. 4.service organization will contact |
| Quantity | 17 |
| Distribution | AL AR AZ CA CO CT DC DE FL GA GU IA ID IL IN KS KY LA MA MD ME MI MN MO MT NC NE NH NJ NY OH OK OR PA SC TN TX VA WA WI WV WY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132119 | MAGNETOM PRISMA, MAGNETOM PRISMA FIT Siemens Medical Solutions USA, Inc., Nov 22, 2013 |