The Recall Desk
SevereFDA (Devices)·Z-2136-2012·Announced 2012-08-15

GE OEC Medical Systems Recalls FluoroTrak Spinal Navigation Application

GE OEC Medical Systems is recalling 17 FluoroTrak Spinal Navigation Applications because they may display incorrect instrument positions relative to reference images.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states the agency classification is Class I. According to the rubric, if the agency's own classification is FDA Class I, the score must never go below 4.

Plain-English summary

GE OEC Medical Systems, Inc. is recalling 17 units of the FluoroTrak Spinal Navigation Application used on the OEC 9900 EliteNAV system. The recall is due to a defect where the application could result in an incorrect position of the navigated instruments versus the displayed reference image.

The affected devices were distributed worldwide, including in the United States (specifically Missouri, Illinois, Louisiana, Florida, New Hampshire, Texas, Indiana, Pennsylvania, and New Jersey) and in France and China. The system is an aid to locate anatomical structures during open or percutaneous surgical procedures, indicated for use in medical conditions that may benefit from stereotactic surgical technique.

The source text does not specify specific actions for consumers or healthcare providers, nor does it report any injuries or illnesses associated with the defect. The recall is classified as Class I by the FDA.

The recalled product

Product
Radiological Image Processing System The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a refe
Manufacturer
GE OEC Medical Systems, Inc
Category
Medical Device — Surgical Navigation
Hazard
Affected units
17

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (17)

  • E9-0002-G
  • ES-0013-G
  • E9-0036-G
  • E9-0040-G
  • E9-0041-G
  • ES-0014-G
  • ES-0016-G
  • ES-0033-G
  • ES-0043-G
  • ES-0041-G
  • ES-0042-G
  • ES-OO84-G
  • ES-0086-G
  • ES-0163-G
  • E9-0089-G
  • ES-0026-G
  • ES-0044-G

Distribution

Distributed in 9 states:

Related recalls

Same manufacturer · GE OEC Medical Systems, Inc

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