Z-1675-2012

Siemens MAGNETOM Essenza, Nuclear Magnetic Resonance Imaging System

Name: Z-1675-2012 Siemens MAGNETOM Essenza, Nuclear Magnetic Resonance Imaging System
Creator: Siemens Medical Solutions USA, Inc
Published: 2012-03-30
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2012-03-30 / Terminated / root cause: labeling and UDI

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens MAGNETOM Essenza, Nuclear Magnetic Resonance Imaging System Product Usage: Nuclear magnetic resonance imaging on 2012-03-30. The reason FDA records is "There is an error in the compatibility data sheet which is part of the System Owner Manual". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1675-2012
Status: Terminated
Initiated: 2012-03-30
Posted: 2012-05-25
Terminated: 2014-04-03
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens MAGNETOM Essenza, Nuclear Magnetic Resonance Imaging System Product Usage: Nuclear magnetic resonance imaging
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: There is an error in the compatibility data sheet which is part of the System Owner Manual
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: 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.

Product code LNH

K071925Class IIMagnetom EssenzaSiemens Medical Solutions USA, Inc. / cleared 2007-08-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)