VitreaCore¿ software
Medical device recall Z-0169-2014. Published in FDA’s Enforcement Report on Nov 13, 2013.
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 Nov 13, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 598 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 II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is 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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Vital Images, Inc. has found an issue in VitreaCore software though internal testing. There is a potential for incorrect and possibly reversed image orientation for certain snapshots taken in VitreaCore software versions 6.0, 6.1, 6.2, 6.3 (except 6.3.1), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
VitreaCore¿ software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3 (except 6.3.1 ), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5. The VitreaCore (ViTALConnect) system is a medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital Images acquired from a variety of imaging devices including: CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. The VitreaCore (ViTALConnect) is not meant for primary Image Interpretation In mammography.
598, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Number 540819 5040918941 CRB1209125 540837 541722 CRB1107015 541783 CRB1211144 540638 CRB1110030 CRA1107015 541350 5060218759 3070900036 540864 CRU1302045 540935 345221 CRB1206107 CRB1108021 540970 540249 CRB1211148 CRB1105014…
Every code shown here, 1,994 characters
Serial Number 540819 5040918941 CRB1209125 540837 541722 CRB1107015 541783 CRB1211144 540638 CRB1110030 CRA1107015 541350 5060218759 3070900036 540864 CRU1302045 540935 345221 CRB1206107 CRB1108021 540970 540249 CRB1211148 CRB1105014 CRB1203085 CRB1212173 541173 3070900134 373677 541633 5080115149 540621 541631 541578 542109 5080111321 5090109540 5080109815 541808 CRU1303050 5080105909 5090102074 5060218090 541618 CRU1303046 CRB1211141 CRU1203031 CRU1209037 542118 5080111550 541541 541782 542085 CRB1305211 CRB1203095 540704 541343 540693 CRB1305217 540641 541603 540322 CRB1103012 CRB1111033 CRB1112037 CRB1203084 541902 5060218686 540651 541531 541821 541997 CRB1302196 541672 542009 CRB1201048 540644 540635 CRB1203064 541554 CRB1302179 5050913152 542224 540614 542046 5060220966 540662 CRB1212154 542197 541233 540648 542195 CRB1109023 542163 541659 541590 540487 541131 CRU1212042 542204 5080122943 5090102031 5080115270 540771 CRB1212161 541645 542020 CRB1203094 CRB1302201 3070900386 CRB1203083 541605 CRB1110028 VESADLSV120900 542087 541355 3070900596 2511 542201 5041210039 5041210179 540702 CRU1303049 CRU1303051 CRU1303047 5050311950 CRB1209126 541843 3070900218 CRB1212167 541110 CRU1212043 540795 541519 CRB1201055 CRB1206108 541289 541835 541922 CRB1201050 CRB1209133 541903 50401210047 CRB1206106 CRB1203068 CRU1211040 CRB1203093 CRB1201056 3070900239 541566 540376 540839 5050911699 5080119470 CSV1303001 542082 CRU1107013 541204 541748 CRB1209121 3070900211 542095 541767 CRA1308021 542126 540552 CRB1212168 540601 5080106980 542005 CRB1109027 CRU1112026 541324 CRB1201049 540678 CRB1302181 541414 542002 541862 3070900421 CRB1305215 540241 540466 542012 CRB1206109 79178 CRB1209139 CRB1302193 541870 5080110910 CRB1209118 541538 540872 540405 CRB1203087 542000 CRB1203067 CRB1203088 CRB1203074 CRB1203079 540415 540886 CRB1302191 542193 CRB1212175 CRB1302180 CRB1212172 CRB1212162 541875 531936 CRB1203072 CRB1306239 CRB1306221 CRU1203030 540914 542175 541956 CRU1112029…
FDA’s list runs to 5,593 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.
Nationwide Distribution - all states in continental USA including DC but not OK or RI. OUS: Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Honduras, Hong Kong, Iceland, Ireland, Italy, Korea, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Qatar, r Saudi Arabia, Serbia, Singapore, Slovenia, South Africa,Spain , Sweden, Switzerland, Thailand, Turkey, Ukraine.
The states and territories these words name
- District of Columbia
They leave out Oklahoma and Rhode Island.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
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 Oct 21, 2013.
- FDA classified it on Nov 6, 2013.
- FDA’s Enforcement Report published it on Nov 13, 2013.
- FDA terminated it on Jan 16, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Vital Images, Inc., of Minnetonka, MN.
- 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 5,593 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
-
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.