MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).
FDA Recall Z-0467-2016 · Posted 2015-12-22
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2015-12-07
Date Terminated2017-06-21
Product Quantityin US 3752 units
Reason for Recall
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.
Firm Action
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.
Root Cause
Other
Distribution Pattern
Nationwide including : DC, PR, Virgin Islands and Bermuda
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K132951MAGNETOM AERASiemens Medical Solutions USA, Inc. · 2013-11-15K133226BIOGRAPH MMRSiemens Medical Solutions USA, Inc. · 2013-11-12K130885MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FITSiemens Medical Solutions USA, Inc. · 2013-05-17K032428MAGNETOM AVANTO MR SYSTEMSiemens Medical Solutions USA, Inc. · 2003-10-16K002179MAGNETOM ALLEGRA SYSTEMSiemens Medical Solutions USA, Inc. · 2000-10-11
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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