Recalls / —

—#108940

Product

Siemens MAGNETOM Essenza, Nuclear Magnetic Resonance Imaging System Product Usage: Nuclear magnetic resonance imaging

FDA product code

LNH — System, Nuclear Magnetic Resonance Imaging

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K071925

Affected lot / code info

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.

Why it was recalled

There is an error in the compatibility data sheet which is part of the System Owner Manual

Root cause (FDA determination)

Error in labeling

Action the firm took

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.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2012-03-30

Posted by FDA

2012-05-25

Terminated

2014-04-03

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #108940. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.