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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens MAGNETOM Essenza, Nuclear Magnetic Resonance Imaging System

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  Class 2 Device Recall Siemens MAGNETOM Essenza, Nuclear Magnetic Resonance Imaging System see related information
Date Initiated by Firm March 30, 2012
Date Posted May 25, 2012
Recall Status1 Terminated 3 on April 03, 2014
Recall Number Z-1675-2012
Recall Event ID 61760
510(K)Number K071925  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product Siemens MAGNETOM Essenza, Nuclear Magnetic Resonance Imaging System


Product Usage:
Nuclear magnetic resonance imaging
Code Information Serial numbers 38293, 38036, 38044, 38096, 38108, 38144, 49011, 38054, 38045, 38184, 38003, 38416, 38334, 38206, 38048, 38183, 38109, 38010, 38301, 38090, 38242, 38014, 38049, 38067, 38105, 38254, 38035, 38375, 38182, 38554, 38075, 38171, 38046, 38340, 38428, 38240, 38130, 38148, 38621, 38247, 38058, 38189, 38201, 38204, 38311, 38106, 49213, 38315, 38299, 49169, 38470, 38256, 38117, 38043, 38059, 38276, 49248, 38295, 38381, 38052, 38478, 38191, 38091, 38362, 38047, 38322, 38368, 38145, 38393, 38455, 38372, 38033, 38209, 38417, 38164, 38015, 38042, 49167, 38538, 38125, 38447, 38155, 38071, 38482, 38020, 38057, 38092, 38312, 38253, 38196, 38346, 38027, 28066, 38325, 38365, 38074, and 38429.
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		 There is an error in the compatibility data sheet which is part of the System Owner Manual
FDA Determined
Cause 2		 Error in labeling
Action Siemens issued a Customer Safety Advisory Notice letter to affected customers on March 30, 2012. The letter identified the affected product, problem, potential risk and what steps can the user take to avoid the potntial risk of this issue. Siemens is releasing corrected pages of the Operator Manual in order to deliver clear guidance and recommendation for the users. Customers are instructed to ensure that the safety advisory and updated pages are replaced in the System Owner Manual.
Quantity in Commerce 97
Distribution US Nationwide Distribution - including the states of AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, LA, MS, MO, NE, NJ, NY, NC, OH, OR, PA, TN, TX, WA, WI, WY and Puerto Rico.
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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