FDA (Devices) recall action 77488

GE Medical Systems, LLC recalled 9 products on 2017-08-23

The FDA (Devices) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.

Products: 9
Announced: 2017-08-23
Critical: 0
Units: 612

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–9 of 9

HighFDA (Devices)··2017-08-23
GE Medical Systems Recalls MRI Scanners Due to Power Supply Wiring
GE Medical Systems is recalling 68 MRI scanners due to possible incorrect wiring in the Uninterruptable Power Supply, which could create a shock hazard.
Product
SIGNA Creator, SIGNA ExplorerProduct Usage: 1.5T SIGNA Creator and 1.5T SIGNA Explorer 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 prod
Category
Distribution
23 states
HighFDA (Devices)··2017-08-23
GE MRI Scanners Recalled for Potential Power Supply Shock Hazard
GE Medical Systems is recalling 68 MRI scanners due to possible incorrect wiring in the uninterruptible power supply, which could create a shock hazard.
Product
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 fo
Category
Distribution
23 states
HighFDA (Devices)··2017-08-23
GE Signa MRI Systems Recalled for Potential Shock Hazard
GE Medical Systems is recalling 68 Signa MRI systems due to possible incorrect wiring in the Uninterruptable Power Supply, which could create a shock hazard.
Product
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¿ H
Category
Distribution
23 states
HighFDA (Devices)··2017-08-23
GE Medical Systems Recalls Discovery MR750 3.0T Scanners for Shock Hazard
GE Medical Systems is recalling 68 Discovery MR750 3.0T MRI scanners due to possible incorrect wiring in the Uninterruptable Power Supply, which could create a shock hazard.
Product
Discovery MR750 3.0T Product Usage: Intended use: The Discovery MR750 3.0Tsystem 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
Category
Distribution
23 states
HighFDA (Devices)··2017-08-23
GE Medical Systems Recalls Signa PET/MR Systems Due to Shock Hazard
GE Medical Systems is recalling 68 Signa PET/MR systems because possible incorrect wiring of the Uninterruptable Power Supply could contribute to a potential shock hazard.
Product
Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired
Category
Distribution
23 states
HighFDA (Devices)··2017-08-23
GE Optima MR750 MRI Scanner Recalled for Potential Shock Hazard
GE Medical Systems is recalling 68 Optima MR750 MRI scanners due to possible incorrect wiring in the Uninterruptable Power Supply, which could create a shock hazard.
Product
Optima MR750 3.0T Product Usage: The Optima MR450 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,
Category
Distribution
23 states
HighFDA (Devices)··2017-08-23
GE Optima MR450w 1.5T MRI Scanner Recalled for Potential Shock Hazard
GE Medical Systems is recalling 68 Optima MR450w 1.5T MRI scanners due to possible incorrect wiring in the Uninterruptable Power Supply, which could create a shock hazard.
Product
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,
Category
Distribution
23 states
HighFDA (Devices)··2017-08-23
GE Brivo and Optima MRI Scanners Recalled for Power Supply Wiring
GE Medical Systems is recalling 68 Brivo MR355 and Optima MR360 MRI scanners due to possible incorrect wiring in the uninterruptible power supply, which could create a shock hazard.
Product
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, sag
Category
Distribution
23 states
HighFDA (Devices)··2017-08-23
GE Medical Systems Recalls Optima MR450 1.5T Scanners for Wiring Defect
GE Medical Systems is recalling 68 Optima MR450 1.5T MRI scanners due to possible incorrect wiring in the Uninterruptable Power Supply, which could create a shock hazard.
Product
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,
Category
Distribution
23 states