GE Medical Systems, LLC: Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise rati

Is my product affected?

Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and obli

• UPC 00840682115971
• UPC 00840682115872
• UPC 00840682103817
• UPC 00840682105699
• UPC 840682105378

Check against the official notice below — it lists the full affected range.

What happened

GE Medical Systems, LLC is recalling 68 units of Brivo MR355 and Optima MR360 magnetic resonance scanners distributed nationwide across 22 states due to possible incorrect wiring of the Uninterruptable Power Supply, which could present a potential shock hazard. The affected units are identified by multiple Medical Device Listing numbers and model numbers for the Uninterruptable Power Supply components.

The record does not specify a remedy or corrective action for consumers to take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.

Details from the source

Reason for recall: Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard. Distribution: US Nationwide in the states of : AK, CA, CO, CT, DE, FL, IA, IL, IN, KS, KY, LA, MD, MO, ND, NE, NJ, NY, OH, PA, TX, WA, and WI Quantity: 68 units in total Lot/code info: Medical Device Listing No. D117354, D295466, D182389, D102432, D206140, D230310, D269569, D102430, D140572, D188736, D102434, D234841, D196247, D134019, D236543, D006275, D159181, D288890, D229859; Model No. Eaton 9130, 5323286, 5396502-5, 5499460-3, 5499460-6, 5499460-9, 5741000-3, 00840682115971, 5396502-2, 5499460-2, 5741000-2, 00840682115872, 5373011-3, 5396469-3, 5481490-2, 5481500-7, 5499460-7, 5499460-10, 5741000, 00840682103817, 5323286-101, 2377062-61, 2395001, 2395001-2, 2395001-3, 2395001-4, 00840682105699, 840682105378

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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