Device recall: OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluoroscopic and spot-film imaging of…
Class II FDA enforcement event 62449. 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. 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 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 27 Mar 2007. The firm address in the FDA record is in Salt Lake City, UT. FDA put the recall in Class II. FDA event 62449 has 3 product records. The first FDA enforcement report date is 8 Aug 2012. The record gives the status Terminated, with the termination date 2 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) and the countries of: Canada, France, Japan, and China.
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
3 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2125-2012 | OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical… | Part of a total of 82 units distributed. | Class II | Terminated | 8 Aug 2012 |
| Z-2126-2012 | OEC MiniView 6800 Mobile; MDL number A349855. Product Usage: The mini 6800 digital mobile c arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical, orthopedic, and extremity imaging. The device is not intended for whole body pediatric… | Part of a total of 82 units distributed. | Class II | Terminated | 8 Aug 2012 |
| Z-2127-2012 | UroView 2800; MDL number A349855. Product Usage: Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical application may include but are not limited to urologic and endoscopic procedures. The system may be ued for other imaging… | Part of a total of 82 units. | Class II | Terminated | 8 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 2007
- 8
- Share of these events in Class II
- 88%
- Product records in this event
- 3Median of the firm: 1
- Events of the firm on the register
- 28
Other events of the firm
Official channels
- FDA enforcement report Z-2125-2012The 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 62449. https://recallregister.com/fda/ii/62449/. 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) and the countries of: Canada, France, Japan, and China.
- What quantity of product is in FDA event 62449?
- The event has 3 product records. The first record gives this quantity:
Part of a total of 82 units distributed.
- How did the recall start?
- The FDA record says:
FDA Mandated
- How many device recalls of 2007 have the same class?
- 88% of the 8 device events that started in 2007 are in Class II.