Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported August 1, 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 whole-body pediatric imaging.
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 Miniv…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ge Oec Medical Systems, Inc recalled OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, su… - a critical-severity action.
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, su… was recalled by Ge Oec Medical Systems, Inc in August 1, 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-2040-2012 with the FDA Devices before acting.
The recall
Ge Oec Medical Systems, Inc issued this critical-severity FDA Devices recall-Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues ….
- Critical
- severity level
- 2K units
- affected scope
- Class I
- classification
- August 1, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2040-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2040-2012) was formally reported on August 1, 2012, with the manufacturer initiating the action on November 20, 2006. It is classified under Critical severity (Class I), 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 1,933 units.
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. The OEC 6800 Miniview was recalled in November 2006 due to… Distribution data in the federal record shows the product reached: Worldwide Distribution. 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1,933 units
Related Recalls
6
3 from same agency
Product description
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 whole-body pediatric imaging.
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. 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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-2040-2012 |
| Date reported | August 1, 2012 |
| Date initiated | November 20, 2006 |
| Recalling firm | Ge Oec Medical Systems, Inc |
| Firm location | Salt Lake City, UT |
| Affected scope | 1,933 units |
| Distribution | Worldwide Distribution |
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-2040-2012) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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 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 whole-body pediatric imaging.. Recalled by Ge Oec Medical Systems, Inc. Units affected: 1,933 units.
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. 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 1, 2012. Severity: Critical. Recall number: Z-2040-2012.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2040-2012) 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 1, 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.