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Terminated

System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

FDA Recall Z-0128-2021 · Posted None

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeLNH
Date Initiated2020-09-08
Date Terminated2021-04-28
Product Quantity30 devices total

Reason for Recall

Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.

Firm Action

On 09/08/20 the firm sent a Customer Letter to its consignees with the following instructions: You can continue to use the system. In the event the PGR cabinet needs to be serviced, power down the PGR at the Main Disconnect Panel (MDP) then follow MDP Lockout/Tagout from the current released service methods and documentation. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction

Root Cause

Process change control

Distribution Pattern

Worldwide distribution - US Nationwide distribution including in the states of FL, KY, NC, NJ, NM, NY, TX, UT and WA. The countries of Canada, Hungary, India, Korea, China, Russia, Taiwan, Puerto Rico and Ubekistan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K163331Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA ArtistGe Medical Systems, LLC · 2017-03-17K091536OPTIMA MR450WGe Medical Systems, LLC · 2009-07-17

Official Source

View FDA Recall →

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

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