Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 8, 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 care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
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 discove…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ge Oec Medical Systems, Inc recalled OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluo… - a moderate-severity action.
OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluo… was recalled by Ge Oec Medical Systems, Inc in August 8, 2012. Reason: Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues …. Check the official notice for the remedy. Verify recall #Z-2125-2012 with the FDA Devices before acting.
The recall
Ge Oec Medical Systems, Inc issued this moderate-severity FDA Devices recall-Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues ….
- Moderate
- severity level
- Class II
- classification
- August 8, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2125-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2125-2012) was formally reported on August 8, 2012, with the manufacturer initiating the action on March 27, 2007. It is classified under Moderate severity (Class II), with a current status of Terminated. Ge Oec Medical Systems, Inc is listed as the recalling firm, operating out of Salt Lake City, UT. Federal records list the affected scope as Part of a total of 82 units distributed..
The documented reason for this recall is: 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 t… Distribution data in the federal record shows the product reached: Worldwide Distribution - US (nationwide) and the countries of: Canada, France, Japan, and China.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
Part of a total of 82 units distributed.
Related Recalls
6
3 from same agency
Product description
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 care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
Reason for recall
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2125-2012 |
| Date reported | August 8, 2012 |
| Date initiated | March 27, 2007 |
| Recalling firm | Ge Oec Medical Systems, Inc |
| Firm location | Salt Lake City, UT |
| Affected scope | Part of a total of 82 units distributed. |
| Distribution | Worldwide Distribution - US (nationwide) and the countries of: Canada, France, Japan, and China. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2125-2012) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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 care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.. Recalled by Ge Oec Medical Systems, Inc. Units affected: Part of a total of 82 units distributed..
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 8, 2012. Severity: Moderate. Recall number: Z-2125-2012.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US (nationwide) and the countries of: Canada, France, Japan, and China..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2125-2012) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 8, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.