Device recall: OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional…
Class I FDA enforcement event 62382. 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. The OEC 6800 Miniview was recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system Lock-up, incorrect image display, incorrect dose area calculated air kerma in "film mo
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 20 Nov 2006. The firm address in the FDA record is in Salt Lake City, UT. FDA put the recall in Class I. FDA event 62382 has 1 product record. The first FDA enforcement report date is 1 Aug 2012. The record gives the status Terminated, with the termination date 13 May 2013.
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
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-2040-2012 | OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for… | 1,933 units | Class I | Terminated | 1 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 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-2040-2012The 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 62382. https://recallregister.com/fda/i/62382/. 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
- What quantity of product is in FDA event 62382?
- The FDA record gives this quantity:
1,933 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2006 have the same class?
- 30% of the 10 device events that started in 2006 are in Class I.