Siemens Medical Solutions USA, Inc: MAGNETOM Avanto, Espree, Trio A Tim System. Nuclear magnetic resonance imaging.

Recall number

Z-2021-2011

Recalling firm

Siemens Medical Solutions USA, Inc

Product

MAGNETOM Avanto, Espree, Trio A Tim System. Nuclear magnetic resonance imaging.

Status

Terminated

Initiated

2011-03-03

Posted

2011-04-18

Terminated

2014-12-09

Reason

Firm discovered during product monitoring that on a few systems the gradient cable connections did not meet their specifications after installation. The potential exists for a cable connection to become overheated, leading to the emission of smoke and possible material damage.

Root cause

Other

Action

Siemens Medical Solutions Inc., issued a Customer Safety Advisory Notice dated November 24, 2010, to affected customers via Update Instructions MR029/10S. Affected customers will be notified via hand delivered letter by Siemens Service Engineers at the time of inspection. A future Update instruction will be released for installation of detectors in appropriate locations on systems to switch off the power electronics in the event of a malfunction in the power supply of the gradient coils. Further questions regarding this recall please call (610) 448-3237.

Quantity

1419

Distribution

Product was distributed domestically to hospitals and imaging centers in the District of Columbia, Puerto Rico, AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY(every State except VT).

Lot, serial or model codes

Model numbers 10018165, 10018221, 10018222, 7387074, 7391167. 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510(k) numbers

["K013586","K032428","K041112","K050200"]

PMA numbers

not on file

Product code

LNH

Firm FEI

2240869

Firm city

Malvern

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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