Device Recall Siemens MAGNETOM MRI Systems with superconducting magnets 의 리콜

Recall

72861

Class 2

Z-0467-2016

2015-12-07

2015-12-22

Terminated

United States

2017-06-21

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142368

Possible installation error of the quench lines of superconducting magnets, used to vent helium gas in the rare event of a quench. any restriction, obstruction, or improper installation of the quench line may cause the helium gas to be blown directly into the magnet room or other areas. this could lead to displacement of oxygen, cause cold burns, and/or pose a risk to users, patient or others.

Siemens sent an Customer Advisory letter dated December 7, 2015, certified mail to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter notifies customers of the potential injuries, which may result of improperly installed quench lines. The letter indicates it is the system's owner who is responsible for installing the quench line per the requirements. If Siemens installed the quench lines, the consignee is directed to contact Siemens, who will inspect the quench lines during next maintenance visit. Siemens will monitor service reports for affected sites. For further questions please call ( 610) 219-6300.