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GE Medical Systems, LLC

GE Medical Systems, LLC Recalls

All product recalls associated with GE Medical Systems, LLC.

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Recall Summary

Total Recalls

1000

Past Year

582

Class I (Serious)

Most Recent

Dec 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 8941–8960 of 10937 recalls

GE Medical Systems, LLC: GE Healthcare Proteus XR/a. Model # 2259988. GE Healthcar...

Certain GE Radiographic fixed X-ray tables (Proteus XR/a, Revolution XR/d, and Definium 8000) were found to have tabletops that move unexpectedly in a bi-directional mode. In rare cases, a malfunction may occur, which could result in the tabletop brakes falling to engage when the control foot pedal is released to lock the floating tabletop in place.

FDAAug 13, 2009Nationwide• GE Medical Systems, LLC

Terumo Cardiovascular Systems Corporation: Safety monitor included with System 8000 Base The Sarns"...

Terumo Cardiovascular Systems (Terumo CVS) received complaints from our Affiliate, Terumo Dubai that the safety monitors were tripping off. Terumo CVS' investigation determined that 8 monitors were manufactured with an underrated circuit breaker due to an error where an associate pulled an underrated circuit breaker from an incorrect inventory location. Since this time, inventory locations hav

FDAAug 12, 2009Nationwide• Terumo Cardiovascular Systems Corporation

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Terumo Cardiovascular Systems Corporation: Safety monitor included with System 8000 Base The Sarn...

Class IIModerate

FDAAug 12, 2009Nationwide• Terumo Cardiovascular Systems Corporation

Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany: BrainLab Radiotherapy Treatment Planning Software; Cata...

Failure to conduct important safety checks when using the BrainLab radiotherapy treatment planning software in combination with BrainLab conical collimators could result in unintended radiation outside the conical shaped field, which may lead to serious injury of the patient.

FDAAug 12, 2009Nationwide• Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany

Boston Scientific CRM Corp: Guidant LATITUDE Communicator, model 6481, Boston Scienti...

The L ATITUDE communicator (Model 6481) for a patient may not have been able to receive measurements from their weight scale or blood pressure monitor afer initial setup. The issue has been resolved. If any patient weight or blood pressure readings are stored in the patient's sensor, they will be uploaded to LATITUDE after the patient's communicator calls in to Boston Scientific's servers. It

FDAAug 7, 2009Nationwide• Boston Scientific CRM Corp

Airgas Puritan Medical Puritan Medical Unit: AGI-2237 Portable 2 Cylinder Manifold Cart, for connectin...

Yoke may become displaced. Yoke index safety system could become compromised, allowing a user to attach the wrong gas type to the yoke connection.

FDAAug 6, 2009Nationwide• Airgas Puritan Medical Puritan Medical Unit

Airgas Puritan Medical Puritan Medical Unit: AGI-2238 Portable 4 Cylinder Manifold Cart, for connectin...

Yoke may become displaced. Yoke index safety system could become compromised, allowing a user to attach the wrong gas type to the yoke connection.

FDAAug 6, 2009Nationwide• Airgas Puritan Medical Puritan Medical Unit

Medtronic Vascular Galway Limited Parkmore Business Park West Galway Ireland: Endeavor Resolute Zotarolimus-Eluting Coronary Stent Syst...

The product was removed from investigational sites due to a packaging issue, in that the device units were packed without the foil pouch, oxygen absorber and Instructions For Use.

FDAAug 6, 2009Nationwide• Medtronic Vascular Galway Limited Parkmore Business Park West Galway Ireland

Philips Medical Systems (Cleveland) Inc: GEMINI TF Big Bore computer tomograph software version 3....

Two non-safety related defects have been found on the Philips GEMINI TF Big Bore running version 3.6; if these defects were to recur, it could impact the performance or reliability of the system. Philips is issuing a software update to all Philips GEMINI TF Big Bore customers to correct these defects.

FDAAug 5, 2009Nationwide• Philips Medical Systems (Cleveland) Inc

Black & Decker Grasshog XP String Trimmer/Edgers (Black & Decker) – laceration risk (2009)

Fire/Burn Risk

The Black & Decker GH1000 Grasshog XP String Trimmers/Edgers are electric-powered. Trimmer/edgers with date codes 200546 through 200645 (representing manufacture dates of November 14, 2005 through November 6, 2006) are included in this recall. The date code is located on the underside of the trimmer/edger's handle. Only trimmers with black spool caps are included in the recall. Those with orange spool caps are not included in the recall.

CPSCAug 4, 2009Nationwide• Black & Decker (U.S.) Inc., of Towson, Md.

Polaris Ranger Side-by-Side Vehicles (Polaris) – fire hazard (2009)

Fire/Burn Risk

The recall involves certain 2009 Polaris Ranger side-by-side, off-road vehicles. The model and serial number identification decal is located under the front seat, on the right-side seat support. The recall includes the models listed below: Model Numbers Model Name R09RF68AF Ranger 700 EFI 6x6 R09RF68AR Ranger 700 EFI 6x6 R09WH68AC Ranger 700 EFI Crew R09WH68AG Ranger 700 EFI Crew R09WH68AL Ranger 700 EFI Crew R09WH68AR Ranger 700 EFI Crew R09WH68AZ Ranger 700 EFI Crew

CPSCAug 4, 2009Nationwide• Polaris Industries Inc., of Medina, Minn.

IMTEC IMAGING L.L.C.: ILUMAVision Software, version 2.1.0 Picture Archiving and...

Under certain circumstances, software Version 2.1.0 has potential for incorrect data imaging and patient identification.

FDAAug 3, 2009Nationwide• IMTEC IMAGING L.L.C.

GE Medical Systems, LLC: Infinia with Hawkeye 1, model numbers: H2508PW, H2508PY, ...

Failure to provide the complete User Manual information.

FDAAug 1, 2009Nationwide• GE Medical Systems, LLC

GE Medical Systems, LLC: Infinia with Hawkeye 4, model numbers: H3000WC and H3000...

Failure to provide the complete User Manual information.

FDAAug 1, 2009Nationwide• GE Medical Systems, LLC

GE Medical Systems, LLC: Millenium VG with Hawkeye/Discovery VH with Hawkeye, mode...

Failure to provide the complete User Manual information.

FDAAug 1, 2009Nationwide• GE Medical Systems, LLC

Linvatec Corp. dba ConMed Linvatec: MC5057 12ft/3.6 meters Universal Cable. Made in USA. NON...

Sufficiently worn/damaged Universal Cable with product number MC5057, when used with various ConMed Linvatec electric Handpieces, may cause the handpiece to self activate.

FDAJul 31, 2009Nationwide• Linvatec Corp. dba ConMed Linvatec

Linvatec Corp. dba ConMed Linvatec: REF IA-2000-S, LightWave Suction Ablator, STERILE, Rx ONL...

Fire/Burn Risk

ConMed Linvatec has determined there is a possibility that the device may not shut off if the ablate button is released, which may result in users/patients suffering burns.

FDAJul 31, 2009Nationwide• Linvatec Corp. dba ConMed Linvatec

GE Medical Systems, LLC: Innova 4100/4100IQ GE Innova 4100 / 4100 IQ. , GE Healthc...

GE Healthcare has recently became aware of a potential power supply failure with the Innova 2000, 3100 and 4100 systems that may impact patient safety. A potential power supply failure inside the GE equipment cabinet could occur with no advance warning and thereby prevent x-ray generation and image processing. Should this occur, the system cannot be restarted.

FDAJul 31, 2009AL, AZ, AR +39 more• GE Medical Systems, LLC

GE Medical Systems, LLC: GE, Innova 2000 The principle system components include a...

FDAJul 31, 2009AL, AZ, AR +39 more• GE Medical Systems, LLC

Linvatec Corp. dba ConMed Linvatec: Mpower PRO6200 Single Trigger Modular Handpiece, Mpower...

There is a potential the devices may self activate for their PowerPro, PowerProMax, and MPower Handpieces manufactured prior to June 1, 2008.

FDAJul 31, 2009Nationwide• Linvatec Corp. dba ConMed Linvatec