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Sign in to claim this brandGE MEDICAL SYSTEMS, INC.
United States·US-MF-000001632
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 3000, N Grandview Blvd, Waukesha, United States
- Website
- gehealthcare.com
- —
- —
- [email protected]
- Phone
- +1(999)999-9999
- PRRC Contact
- Chris Paulik
- EUDAMED SRN
- US-MF-000001632
- FDA FEI Number
- 2126677
- DUNS Number
- 809785715
Catalogue (373)
Page 1 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Revolution UPG 5 | Revolution UPG 5 | EUDAMED | Class IIb | Active |
| Revolution Vibe | K250941 | FDA 510(k) | Class II | Active |
| GenIQ | K143368 | FDA 510(k) | Class II | Active |
| Amx | Navigate | FDA UDI | Class II | Active |
| Discovery | IGS 730 002 | FDA UDI | Class II | Unknown |
| Insight Discovery Thermal (w/cable) | 900-014-2 | FDA UDI | Class II | Active |
| Pristina Paddle | SLD FX | FDA UDI | Class I | Active |
| Senographe Pristina | NAY3 | FDA UDI | Class II | Active |
| Innova | IGS 620 002 | FDA UDI | Class II | Unknown |
| Revolution | CT with Apex edition | FDA UDI | Class II | Active |
| O560 to 610 Upgrade | 5607000-2 | FDA UDI | Class II | Active |
| Optima | XR240amx HD Upgrade | FDA UDI | Class II | Active |
| The Spanner Temporary Prostatic Stent | The Spanner Stent Size 6 | FDA UDI | Class III | Active |
| Senographe Pristina | NAY2 | FDA UDI | Class II | Active |
| Discovery Base Unit | 900-010 | FDA UDI | Class II | Active |
| EP1 VP Test Pressure Kit, Single | 730-001 | FDA UDI | Class II | Active |
| Flashpad HD | 2530 | FDA UDI | Class II | Active |
| Precision | 600FP | FDA UDI | Class II | Active |
| Revolution | CT Power | FDA UDI | Class II | Active |
| The Spanner Temporary Prostatic Stent | The Spanner Stent Size 7 | FDA UDI | Class III | Active |
| SenoBright | GPE1 | FDA UDI | Class II | Unknown |
| Innova | IGS 520 002 | FDA UDI | Class II | Unknown |
| The Spanner Temporary Prostatic Stent | The Spanner Stent Size 8 | FDA UDI | Class III | Active |
| Discovery PET CT | 690 VCT Boost Upgrade | FDA UDI | Class II | Active |
| Discovery | MI | FDA UDI | Class II | Active |
| Discovery | IGS 7 001 | FDA UDI | Class II | Unknown |
| Discovery | IQ | FDA UDI | Class II | Active |
| INTERACT Discovery | RT 001 | FDA UDI | Class II | Unknown |
| EMG Elect. w/Lead Wire Set, EP (1 set of 3/bag) | 35700015S | FDA UDI | Class II | Active |
| Senographe Pristina 3D | ATA1 | FDA UDI | Class III | Active |
| SenoIris | 1 | FDA UDI | Class II | Active |
| CT3000 Base Unit | 900-027 | FDA UDI | Class II | Active |
| Senographe Pristina | EKB4 | FDA UDI | Class II | Active |
| The Spanner Temporary Prostatic Stent | The Spanner Stent Size 9 | FDA UDI | Class III | Active |
| Innova | IGS 3 001 | FDA UDI | Class II | Unknown |
| Pristina Paddle | 24x29 STD | FDA UDI | Class I | Active |
| Revolution | Discovery CT | FDA UDI | Class II | Active |
| Discovery MI Columbird mE2 Application SW | 2.0 | FDA UDI | Class II | Active |
| Critical Care Suite | 2.1 | FDA UDI | Class II | Active |
| Discovery IQ | OpenOC16 Console Upgrade | FDA UDI | Class II | Active |
| MagStand 1.8 | MAG8 | FDA UDI | Class I | Active |
| Revolution | 160mm Detector Upgrade | FDA UDI | Class II | Active |
| EasyFlo Base Unit | 84411314 | FDA UDI | Class II | Active |
| MagStand 1.5 | MAG5 | FDA UDI | Class I | Active |
| Discovery | PETCT 610 | FDA UDI | Class II | Active |
| Senographe Essential | ES14 | FDA UDI | Class II | Unknown |
| Discovery | MI Digital Ready | FDA UDI | Class II | Active |
| Senographe Pristina | EKB2 | FDA UDI | Class II | Active |
| UroFlow Scale | 900-042 | FDA UDI | Class II | Active |
| Discovery | IGS 740 002 | FDA UDI | Class II | Unknown |
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FDA Recalls (7)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 16, 2020 | Z-0569-2021 | — | terminated | Due to footswitch not meeting required specification for protection from ingress of solids or liquids. If spilling of liquids near or on the footswitch, it may fail in the 'on' position and allow the laser to continue to lase. |
| Jul 24, 2020 | Z-0050-2021 | — | terminated | Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury. |
| Jan 23, 2020 | Z-2497-2020 | — | terminated | A software issue was identified which could result in user or patient injury, or may adversely impact laser performance. It is possible that an unintended release of laser light (radiation) may occur, injuring the user or patient. |
| Sep 19, 2019 | Z-2006-2020 | — | terminated | The firm has become aware there is a potential problem with its DABRA catheters resulting in higher catheter calibration failure rate due to the product shelf life is currently less than the labeled shelf life. |
| Aug 23, 2019 | Z-1631-2020 | — | terminated | At doses of less than 100 mJ, in custom and auto repeat modes, a software error in the excimer laser phototherapy system causes the device to fail to cease firing as long as the foot pedal or handpiece switch is depressed. This malfunction can cause overtreatment, which could result in strong erythema, and possibly cause blisters. |
| Feb 15, 2018 | Z-2218-2019 | — | terminated | Lasers/Catheters did not calibrate during set-up prior to use. |
| Jun 30, 2014 | Z-2123-2014 | — | terminated | RA Medical Systems is recalling the PHAROS EX-308 Excimer Laser because there is a possibility that the laser may calibrate with the iris closed. |