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GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc Recalls

All product recalls associated with GE OEC Medical Systems, Inc.

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Recall Summary

Total Recalls

111

Past Year

0

Class I (Serious)

6

Most Recent

Nov 2024

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 41–60 of 111 recalls

GE OEC Medical Systems, Inc: GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Health...

X-ray units did not meet manufacturer's specification for linearity.

FDAOct 19, 2007Nationwide• GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc: GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Health...

X-ray units did not meet manufacturer's specification for linearity.

Class IIModerate

FDAOct 19, 2007Nationwide• GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc: GE OEC, Insta Trak 3500 Plus with the Cranial Application...

Crack, Fracture or Detachment: The Transmitter Arm for the Mayfield-compatible Transmitter may become detached from the unit and enter into the surgical field.

Page 3 of 6Next

FDA

Oct 18, 2007

AL, AZ, AR +22 more

• GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc: GE Healthcare, Mobile Fluoroscopy X-Ray System, OEC Model...

Unnecessary operator exposure; X-ray machine may allow unwanted x-ray exposure to the operator.

FDASep 28, 2007CO, DE, FL +6 more• GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc: GEHC OEC 9800 ESP-15 C-Arm fluoroscopic X-ray system, GE ...

The Air Kerma Rate displayed value and cumulative air kerma displayed value could exceed the allowable error under certain imaging conditions.

FDAJul 6, 2007Nationwide• GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc: GEHC OEC 9900 ESP-15 Elite C-Arm fluoroscopic X-ray syste...

The Air Kerma Rate displayed value and cumulative air kerma displayed value could exceed the allowable error under certain imaging conditions.

FDAJul 6, 2007Nationwide• GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc: GE OEC 8800 Fluoroscopic X-ray System, GE Healthcare, Sal...

X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma.

FDAJun 12, 2007CO, FL, GA +4 more• GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc: GE OEC 9900 Elite Fluoroscopic X-ray System, GE Healthcar...

X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma.

FDAJun 12, 2007CO, FL, GA +4 more• GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc: GE OEC 9800 Fluoroscopic X-ray System, GE Healthcare, Sal...

X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma.

FDAJun 12, 2007CO, FL, GA +4 more• GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc: GE OEC 6800 Fluoroscopic X-ray System, GE Healthcare, Sal...

X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma.

FDAJun 12, 2007CO, FL, GA +4 more• GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc: GE OEC 2800 mobile Fluoroscopic X-ray System, GE Healthca...

X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma.

FDAJun 12, 2007CO, FL, GA +4 more• GE OEC Medical Systems, Inc

OEC Medical Systems, Inc: OEC Miniview 6800 mobile fluoroscopic x-ray system, GE He...

X-ray systems did not have the required labeling to indicate Air Kerma Rate and cumulative Air Kerma during fluoroscopic procedures

FDAMay 24, 2007AK, CA, CO +16 more• OEC Medical Systems, Inc

GE OEC Medical Systems, Inc: Cleaning probe included as an accessory to aspirators tha...

Cleaning probes used to unclog disposable aspirators may shed small particles of nylon material which may be transferred into the nasal cavity.

FDAMay 18, 2007Nationwide• GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc: Radiological Image Processing System The system is an ai...

The FluoroTrak Spinal Navigation Application on the OEC 9900 EliteNAV could result in an incorrect position of the navigated instrument(s) versus the displayed reference image.

FDAApr 2, 2007FL, IL, IN +6 more• GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc: Radiological Image Processing System The system is an ...

The FluoroTrak Spinal Navigation Application on the OEC 9900 EliteNAV could result in an incorrect position of the navigated instrument(s) versus the displayed reference image.

FDAApr 2, 2007FL, IL, IN +6 more• GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc: OEC 9800 Plus Digital; MDL number A349855. Product Usa...

Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15, 2004 and

Class IIModerate

FDAMar 27, 2007Nationwide• GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc: OEC MiniView 6800 Mobile; MDL number A349855. Product ...

Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15, 2004 and

Class IIModerate

FDAMar 27, 2007Nationwide• GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc: OEC MiniView 6800 Mobile; MDL number A349855. Product Us...

Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15, 2004 and

FDAMar 27, 2007Nationwide• GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc: UroView 2800; MDL number A349855. Product Usage: Designe...

Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15, 2004 and

FDAMar 27, 2007Nationwide• GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc: OEC 9800 Plus Digital; MDL number A349855. Product Usage...

Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15, 2004 and

FDAMar 27, 2007Nationwide• GE OEC Medical Systems, Inc