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Terminated

GE Healthcare-Americas Signa 3.0T EXCITE Whole Body Magnetic Resonance System

FDA Recall Z-0815-2007 · Posted 2007-05-18

Recalling FirmGE Medical Systems LLC
Recall StatusTerminated
Product CodeLNH
Date Initiated2006-06-01
Date Terminated2008-02-24
Product Quantity30 units

Reason for Recall

To provide the 3.0T MRI systems users with the 8-channel brain coil the proper coil weighting software. The proper coil weighting factors for the eight-channel brain coil were not included in the software.

Firm Action

The corrective action is already completed and all customers have been notified via a personal visit to each site, to install a software patch beginning June, 2006.

Root Cause

Other

Distribution Pattern

Worldwide, including USA, China, Finland, Germany, Israel, Italy, Korea, Spain, and Taiwan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040444GE SIGNA 3.0T WITH EXCITE MR SYSTEMGeneral Electric Co. · 2004-04-14

Official Source

View FDA Recall →

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

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