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Terminated

Siemens MAGNETOM Systems Symphony, Sonata and Symphony a TIM System Nuclear magnetic resonance imaging system

FDA Recall Z-2786-2011 · Posted 2011-07-11

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2011-03-31
Date Terminated2014-01-08
Product Quantity440

Reason for Recall

Firm has discovered during product monitoring that on a few systems the gradient cable connections did not meet their specifications after installation.

Firm Action

Siemens initated their recall of the device on March 31, 2001, by sending a Customer Safety Advisory Notice/Letter to affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were notified that detectors will be installed in appropriate locations on the system, which will switch off the system's power electronics in the event of a malfunction in the power supply of the gradient coils, preventing damage to the system and its environment.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution including AL, 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, VT, VA, WA, WV, and WI and Puerto Rico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K993731SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEMSiemens Medical Solutions USA, Inc. · 1999-12-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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