Optima MR450 1.5T Product Usage: 1 .5T Brivo MR355 and 1.5T Optima MR360 are whole body magnetic resonance scanners 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 o
Check against the official notice below — it lists the full affected range.
GE Medical Systems, LLC is recalling 68 units of Optima MR450, Brivo MR355, and Optima MR360 magnetic resonance scanners due to possible incorrect wiring of the Uninterruptable Power Supply, which could create a potential shock hazard. The affected devices were distributed nationwide across 22 states including California, Texas, New York, Florida, and Pennsylvania.
The recall notice does not specify a remedy or recommended action for consumers who may have affected devices.
Written by software from the official notice below. Not reviewed by a lawyer.
Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.