MAGNETOM Prisma magnetic resonance diagnostic devices Model #10849582
This recall has been terminated (originally issued July 9, 2019).
- Recall Initiated
- July 9, 2019
- Terminated
- April 23, 2020
- Recall Number
- Z-2345-2019
- Quantity
- 17
- Firm Location
- Malvern, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.
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
Lot / Code Info
Serial # 66109 66111 166049 66047 166037 66102 66027 66053 66094 66028 66069 66092 66046 66082 166097 66044 166082
Root Cause
Device Design
Action Taken
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 you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. 5. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Customer Safety Advisory Notice. By signing this document you are acknowledging that you have read and understand the content therein. If you have any question, please contact Meredith Adams, Telephone 610-448-6461 and E-Mail: Meredith.adams@siemens-healthineers.com