OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and…
Medical device recall Z-2040-2012. Published in FDA’s Enforcement Report on Aug 1, 2012.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Aug 1, 2012. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 1,933 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is 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.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are 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.
1,933 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
86-1834 , 86-1175 , 86-0238 , 86-0585 , 86-1230 , 86-1992 , 86-0184 , 86-1033 , 86-1480 , 86-1369 , 86-0579 , 86-1678 , 86-1059 , 86-0639 , 86-0389 & 86-0390 , 86-0775 , 86-0850 & 86-1703 , 86-0151 & 86-1311 , 86-1883 , 86-0048 & 86-2015 ,…
Every code shown here, 1,999 characters
86-1834 , 86-1175 , 86-0238 , 86-0585 , 86-1230 , 86-1992 , 86-0184 , 86-1033 , 86-1480 , 86-1369 , 86-0579 , 86-1678 , 86-1059 , 86-0639 , 86-0389 & 86-0390 , 86-0775 , 86-0850 & 86-1703 , 86-0151 & 86-1311 , 86-1883 , 86-0048 & 86-2015 , 86-0915, 86-1626 & 86-1631 , 86-2118 , 86-0949 , 86-0937 , 86-0071 & 86-1015 , 86-0352 , 86-0527 , 86-0140 , 86-1697 , 86-0697 , 86-1162 , 86-1424 , 86-0795 , 86-0260 , 86-0077 , 86-2002 , 86-0811 , 86-2148 , 86-1582 , 86-1633 , 86-0454 , 86-0185, 86-1119 & 86-1885 , 86-0668 , 86-1026 , 86-0529 , 86-1754 , 86-0901 , 86-0228 , 86-1555 , 86-1212 , 86-1095 , 86-0997 , 86-1475 , 86-2137 , 86-0829 , 86-1737 , 86-1259 , 86-0013 , 86-1139 , 86-0058 , 86-0327 , 86-1346 , 86-0419 & 86-2047 , 86-1892 , 86-0359 & 86-1070 , 86-0331 , 86-1255 , 86-0785 , 86-1043 , 86-1854 , 86-0148 & 86-1036 , 86-0427 & 86-2068 , 86-1988 , 86-0092 , 86-1283 , 86-1955 , 86-0711 , 86-2035 , 86-2017 , 86-0770 & 86-2044 , 86-0716 , 86-0692 , 86-1610 , 86-0154 & 86-1822 , 86-1727 , 86-1209 & 86-1210 , 86-0046 , 86-1303 , 86-0468 , 86-1274 , 86-0113 , 86-0035 , 86-1481 , 86-1808 , 86-1332 , 86-0618 , 86-1860 , 86-0425 , 86-0912 , 86-0925 , 86-0306 & 86-0664 , 86-0987 , 86-2170 , 86-0308 , 86-1302 , 86-0399 , 86-1205 , 86-1615 , 86-2128 , 86-0162 , 86-0166 , 86-0105 , 86-1687 & 86-1844 , 86-0865 , 86-1045 , 86-1360 , 86-0903 , 86-1456 , 86-1213 , 86-1326 , 86-0745 , 86-0517 , 86-2140 , 86-0625 & 86-1399 , 86-0923 , 86-1319 & 86-2133 , 86-1499 , 86-1823 , 86-0401 , 86-0157 , 86-0685 , 86-0570 , 86-1446 , 86-1606 , 86-2030 , 86-0086 , 86-0075 & 86-0076 , 86-0435 , 86-1780 , 86-0247-RC , 86-1478 , 86-1894 , 86-0896 , 86-1249 , 86-0601, 86-0914 & 86-1248 , 86-1250 , 86-1836 , 86-0805, 86-0806 & 86-0972 , 86-1619 , 86-1576 , 86-0544 , 86-1886 , 86-1782 , 86-0475 , 86-0321 , 86-0511 , 86-1949 , 86-1150 , 86-1065 , 86-1614 , 86-1907 , 86-1625 , 86-0757 & 86-0786 , 86-2092 , 86-0501 , 86-2117 , 86-1879 , 86-1714 , 86-0416 , 86-1506 , 86-1732 , 86-0977 , 86-0964 , 86-1531 ,…
FDA’s list runs to 21,669 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 20, 2006.
- FDA classified it on Jul 24, 2012.
- FDA’s Enforcement Report published it on Aug 1, 2012.
- FDA terminated it on May 13, 2013.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE OEC Medical Systems, Inc, of Salt Lake City, UT.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 21,669 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.