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GE Medical Systems Ultrasound & Primary Care Diagnostics, LL Recalls
12 recalls on record · April 25, 2018 to September 12, 2018 · Medical Devices
September 12, 2018Medical DevicesFDA
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL recalls GE Vivid E7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound system, specialized for use in
Hazard: The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
September 12, 2018Medical DevicesFDA
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL recalls GE Vivid 7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound system, specialized for use in c
Hazard: The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
September 12, 2018Medical DevicesFDA
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL recalls GE Vivid E95 ultrasound system Product The device is intended for use by a qualified physician for ultrasound evaluat
Hazard: The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
September 12, 2018Medical DevicesFDA
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL recalls GE Vivid E90 ultrasound system Product Usage: Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound s
Hazard: The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
September 12, 2018Medical DevicesFDA
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL recalls GE Vivid E80 ultrasound system Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, special
Hazard: The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
September 12, 2018Medical DevicesFDA
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL recalls GE Vivid E9 ultrasound system Product Usage: GE Vivid E9 ultrasound system is a general purpose ultrasound syste
Hazard: The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
September 12, 2018Medical DevicesFDA
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL recalls GE LOGIQ 9 ultrasound system Product Usage: The device is intended for use by a qualified physician for ultrasound
Hazard: The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
September 12, 2018Medical DevicesFDA
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL recalls GE LOGIQ E9 ultrasound system Product Usage: The device is intended for use by a qualified physician for ultrasound
Hazard: The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
July 25, 2018Medical DevicesFDA
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL recalls T2100 Micro flex Drive Treadmill, powered Product Usage: Powered exercise equipment consist of powered devices inte
Hazard: A performance issue with customer owned spare parts, T2100 Microflex drive (2026182-002 or 2026182-004), was not addressed with a previous safety correction. If these parts were installed from customer owned stock on the T2100 Treadmill, uncontrolled walking belt motion during a stress exercise test could occur.
April 25, 2018Medical DevicesFDA
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL recalls GE Healthcare: a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU40626, LU40637, LU4202
Hazard: Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient information in the DICOM header. The correct patient information will be listed on the DICOM report image; however, the report may appear under a different patients name in the PACS.
April 25, 2018Medical DevicesFDA
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL recalls GE Healthcare Lunar: a) DPX NT, Model Numbers: LU8230, LU40338, LU42357, LU42369 b) DPX MD+, Model Numbers: LU8230,
Hazard: Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient information in the DICOM header. The correct patient information will be listed on the DICOM report image; however, the report may appear under a different patients name in the PACS.
April 25, 2018Medical DevicesFDA
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL recalls GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model Number: LU41692 Provides an estimate o
Hazard: Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient information in the DICOM header. The correct patient information will be listed on the DICOM report image; however, the report may appear under a different patients name in the PACS.