CARESCAPE VC150 Vital Signs Monitor
Medical device recall Z-2604-2016. Published in FDA’s Enforcement Report on Aug 31, 2016.
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 31, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 15 states named in where it went
- 1715 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 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?
A software error on released software versions 1.6.12, 1.6.12F and 1.6.16 may give wrong time data to measurements.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient’s vital signs at the site of care.
1715 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
SK514130002YA SK514130016YA SK514150001YA SK514150017YA SK514150020YA SK514150021YA SK514150022YA SK514150032YA SK514450012YA SK514470018YA SK514490005YA SK514490006YA SK514490009YA SK514490010YA SK514490011YA SK514490012YA SK515040001YA…
Every code shown here, 1,988 characters
SK514130002YA SK514130016YA SK514150001YA SK514150017YA SK514150020YA SK514150021YA SK514150022YA SK514150032YA SK514450012YA SK514470018YA SK514490005YA SK514490006YA SK514490009YA SK514490010YA SK514490011YA SK514490012YA SK515040001YA SK515050016YA SK515050017YA SK515050018YA SK515050019YA SK515050020YA SK515050021YA SK515050022YA SK515050023YA SK515050024YA SK515050025YA SK515060001YA SK515060002YA SK515060003YA SK515060005YA SK515100057YA SK515100065YA SK515100066YA SK515100068YA SK515110063YA SK515110066YA SK515110073YA SK515110118YA SK515110174YA SK515110183YA SK515110184YA SK515110185YA SK515110186YA SK515110187YA SK515110188YA SK515110189YA SK515110190YA SK515110192YA SK515110193YA SK515110195YA SK515120002YA SK515120003YA SK515120004YA SK515120007YA SK515120008YA SK515120012YA SK515120015YA SK515120017YA SK515120018YA SK515120040YA SK515120042YA SK515120043YA SK515120044YA SK515120045YA SK515120046YA SK515120048YA SK515120049YA SK515120050YA SK515120051YA SK515120052YA SK515130007YA SK515130024YA SK515150036YA SK515160006YA SK515160010YA SK515160016YA SK515160017YA SK515160018YA SK515160022YA SK515160024YA SK515160025YA SK515160028YA SK515160030YA SK515160034YA SK515160035YA SK515160036YA SK515160037YA SK515160039YA SK515160040YA SK515160043YA SK515160044YA SK515160045YA SK515160047YA SK515160048YA SK515160049YA SK515160050YA SK515160051YA SK515160052YA SK515160053YA SK515160054YA SK515160055YA SK515160056YA SK515160057YA SK515180004YA SK515180006YA SK515230005YA SK515230006YA SK515230007YA SK515230008YA SK515230009YA SK515230012YA SK515230014YA SK515230015YA SK515230016YA SK515230017YA SK515230018YA SK515230020YA SK515240010YA SK515260002YA SK515260003YA SK515260004YA SK515260005YA SK515260006YA SK515260007YA SK515260008YA SK515260009YA SK515260010YA SK515260011YA SK515260012YA SK515260013YA SK515260014YA SK515260015YA SK515260016YA SK515260017YA SK515260018YA SK515260019YA SK515260020YA SK515270002YA SK515270004YA SK515270011YA SK515270012YA…
FDA’s list runs to 24,009 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.
AR, AZ, FL, IN, LA, MA, MI, NC, NJ, NM, NY, OH, PA, TN, WI
The states and territories these words name
15 states and territories.
Every one of them
- Arkansas
- Arizona
- Florida
- Indiana
- Louisiana
- Massachusetts
- Michigan
- North Carolina
- New Jersey
- New Mexico
- New York
- Ohio
- Pennsylvania
- Tennessee
- Wisconsin
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 Jul 27, 2016.
- FDA classified it on Aug 19, 2016.
- FDA’s Enforcement Report published it on Aug 31, 2016.
- FDA terminated it on Apr 19, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- INNOKAS MEDICAL OY, of KEMPELE, Finland.
- 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 24,009 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.