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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens MAGNETOM Aera/Skyra

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  Class 2 Device Recall Siemens MAGNETOM Aera/Skyra see related information
Date Initiated by Firm January 26, 2012
Date Posted February 02, 2012
Recall Status1 Terminated 3 on January 31, 2014
Recall Number Z-0940-2012
Recall Event ID 61030
510(K)Number K101347  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product Siemens MAGNETOM Aera/Skyra, model numbers 10432914 and 10432915.

Nuclear magnetic resonance imaging system.
Code Information Serial numbers 45115, 41187, 41157, 41116, 45072, 45081, 41089, 41215, 41144, 41201, 45148, 41164, 41088, 41245, 41168, 41152, 45140, 45152, 45143, 45195, 41222, 41150, 45129, 45118, 45119, 41134, 41138, 45182, 45213, 41167, 41100, 52024, 45196, 45197, 41180, 41130, 45088, 41189, 41104, 41246, 41176, 45138, 15084, 41071, 45120, 45107, 41271, 45135, 45141, 41264, 45110, 41279, 41231, 41284, 41235, 45221, 45223, 41276, 41278, 41137, 41225, 41131, 41141, 41233, 45185, 41236, 41238, 45149, 41191, 45074, 45106, 45006, 45201, 41133, 41265, 41188, 45220, 41140, 41079, 45160, 45167, 41194, 45155, 45130, 41241, 41170, 45147, 41006, 45219, 45085, 45150, 45031, 41162, 45121, 45134, 45099, 45038, 45079, 41109, 41156, 45116, 41249, 45128, 45078, 45214, 41103, 45229, 41234, 45181, 52025, 52021, 45105, 45132, 41149, 45228, 45060, 45080, 45208, 41083, 45230, 45205, 41097, 41181, 45093, 45199, 45184, 45071, and 45111.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Anastasia Mason
610-219-4834
Manufacturer Reason
for Recall		 During product monitoring firm has discovered that on a few systems the gradient cable connections did not meet their specifications after installation. Locally, the cable connections overheated, making servicing necessary. The potential existed for a cable connection to become overheated, leading to the emission of smoke and possible material damage. Firm preventively checked the gradient cabl
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens Medical Solutions sent a "CUSTOMER SAFETY ADVISORY NOTICE" letter dated November 24, 2010 to all affected customers. The letter described the product, problem, and actions to be taken. Contact the firm at 610-219-4834 for questions regarding this recall.
Quantity in Commerce 128
Distribution Nationwide Distribution-including the states of AK, AZ, CA, CT, DE, FL, GA, IL, IN, KS, MD, MA, MI, MN, MO, MT, NE, NH, NJ, NM, NY, NC, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, and WI.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA INC.
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