Optima MR450w 1.5T Product Usage: The Optima MR450w 1.5T system 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 oblique im
Check against the official notice below — it lists the full affected range.
GE Medical Systems is recalling 68 units of the Optima MR450w 1.5T magnetic resonance imaging scanner due to possible incorrect wiring of the Uninterruptable Power Supply that could create a potential shock hazard. The affected devices were distributed nationwide across 22 states: Alaska, California, Colorado, Connecticut, Delaware, Florida, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Missouri, North Dakota, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Washington, and Wisconsin.
The recall affects units with multiple medical device listing numbers and model numbers. The source does not specify a remedy or what action affected consumers should take.
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.