—#142368

Product

MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K002179, K032428, K130885, K132951, K133226
Affected lot / code info: all units distributed since 1991

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: Nationwide including : DC, PR, Virgin Islands and Bermuda

Timeline

Recall initiated: 2015-12-07
Posted by FDA: 2015-12-22
Terminated: 2017-06-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #142368. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.