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GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
FDA Regulatory Profile
Summary
- Total Recalls
- 12
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2467-2018 | Class II | T2100 Micro flex Drive Treadmill, powered Product Usage: Powered exercise equipment consist of | April 2, 2018 |
| Z-2985-2018 | Class II | GE Vivid E9 ultrasound system Product Usage: GE Vivid E9 ultrasound system is a general purp | March 22, 2018 |
| Z-2987-2018 | Class II | GE Vivid E90 ultrasound system Product Usage: Vivid E80 / E90 / E95 ultrasound system is general- | March 22, 2018 |
| Z-2983-2018 | Class II | GE LOGIQ E9 ultrasound system Product Usage: The device is intended for use by a qualified physi | March 22, 2018 |
| Z-2984-2018 | Class II | GE LOGIQ 9 ultrasound system Product Usage: The device is intended for use by a qualified phys | March 22, 2018 |
| Z-2986-2018 | Class II | GE Vivid E80 ultrasound system Vivid E80 / E90 / E95 ultrasound system is general-purpose ultraso | March 22, 2018 |
| Z-2989-2018 | Class II | GE Vivid 7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound system, spec | March 22, 2018 |
| Z-2990-2018 | Class II | GE Vivid E7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound system, spe | March 22, 2018 |
| Z-2988-2018 | Class II | GE Vivid E95 ultrasound system Product The device is intended for use by a qualified physician fo | March 22, 2018 |
| Z-1393-2018 | Class II | GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model Number: LU41692 Pr | March 16, 2018 |
| Z-1394-2018 | Class II | GE Healthcare Lunar: a) DPX NT, Model Numbers: LU8230, LU40338, LU42357, LU42369 b) DPX MD+, Mode | March 16, 2018 |
| Z-1395-2018 | Class II | GE Healthcare: a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU40 | March 16, 2018 |