GE Medical Systems, LLC: 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner desig

Is my product affected?

1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are 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 ima

• 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 is recalling 68 units of its 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, and Signa Vibrant magnetic resonance scanners distributed nationwide across 22 states. The recall was initiated due to possible incorrect wiring of the Uninterruptable Power Supply that could create a potential shock hazard.

The affected devices are identified by specific Medical Device Listing numbers and model numbers listed in the recall notice. According to the recall record, no remedy information is specified.

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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