GE Medical Systems, LLC: 1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The GE Signa¿ HDx MR system is a whole body magnetic resonance scanne

Is my product affected?

1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The GE Signa¿ HDx MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa¿ HDx MR system is indicate

• 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 Signa HDx, Signa HDxt, Signa HDi, and Signa Vibrant magnetic resonance scanner systems distributed nationwide across 23 states. The recall was initiated due to possible incorrect wiring of the Uninterruptable Power Supply, which could create a potential shock hazard.

The affected units are identified by various Medical Device Listing numbers and model numbers provided in the recall notice. However, the source document does not specify a remedy or corrective action for affected consumers.

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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