Device recall: OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures…
Class II FDA enforcement event 62744. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
GE Healthcare had recalled certain OEC InstaTrak 3500 Carts due to the potential for the cart to tip over when the arm of the imaging device is extended during use.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
GE OEC Medical Systems, Inc started this device recall on 11 Oct 2006. The firm address in the FDA record is in Salt Lake City, UT. FDA put the recall in Class II. FDA event 62744 has 1 product record. The first FDA enforcement report date is 29 Aug 2012. The record gives the status Terminated, with the termination date 22 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.
Nationwide Distribution.
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: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2236-2012 | OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures during open 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 reference to rigid… | 99 units | Class II | Terminated | 29 Aug 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 II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2006
- 10
- Share of these events in Class II
- 60%
- 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-2236-2012The 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 62744. https://recallregister.com/fda/ii/62744/. 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:
Nationwide Distribution.
- What quantity of product is in FDA event 62744?
- The FDA record gives this quantity:
99 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2006 have the same class?
- 60% of the 10 device events that started in 2006 are in Class II.