Device recall: InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus.…
Class I FDA enforcement event 62112. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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. On October 11, 2006, GE Healthcare recalled GE OEC InstaTrak 3500 Plus System with Software version 5.2, the surgical Navigation and Visualization Application due to software related issues.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
GE OEC Medical Systems, Inc started this device recall on 15 Sep 2006. The firm address in the FDA record is in Salt Lake City, UT. FDA put the recall in Class I. FDA event 62112 has 1 product record. The first FDA enforcement report date is 18 Jul 2012. The record gives the status Terminated, with the termination date 21 Aug 2012.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution - US (nationwide)
Recalling firm
GE OEC Medical Systems, Inc, Salt Lake City, UT.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: FDA Mandated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1985-2012 | InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product Usage: Usage: 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… | 86 units | Class I | Terminated | 18 Jul 2012 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2006
- 10
- Share of these events in Class I
- 30%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 28
Other events of the firm
Official channels
- FDA enforcement report Z-1985-2012The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 62112. https://recallregister.com/fda/i/62112/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution - US (nationwide)
- What quantity of product is in FDA event 62112?
- The FDA record gives this quantity:
86 units
- How did the recall start?
- The FDA record says:
FDA Mandated
- How many device recalls of 2006 have the same class?
- 30% of the 10 device events that started in 2006 are in Class I.