CAPNOSTREAM 20P (US) N W/PRINTER - ROHS
Medical device recall Z-0027-2019. Published in FDA’s Enforcement Report on Oct 10, 2018.
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 Oct 10, 2018. 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
- 696 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?
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03
696, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
PA10170221 PA10170222 PA10170224 PA10170226 PA10170227 PA10170238 PA10170240 PA48160004 PA48160009 PA48160011 PA48160012 PA50160014 PA50160017 PA50160021 PA50160023 PA50160024 PA50160025 PA50160026 PA50160027 PA50160028 PA50160029…
Every code shown here, 1,991 characters
PA10170221 PA10170222 PA10170224 PA10170226 PA10170227 PA10170238 PA10170240 PA48160004 PA48160009 PA48160011 PA48160012 PA50160014 PA50160017 PA50160021 PA50160023 PA50160024 PA50160025 PA50160026 PA50160027 PA50160028 PA50160029 PA50160030 PA51160034 PA51160035 PA51160036 PA51160037 PA51160038 PA51160039 PA51160040 PA51160041 PA51160042 PA51160043 PA51160044 PA51160045 PA51160046 PA51160047 PA51160048 PA51160049 PA51160050 PA51160051 PA51160053 PA51160054 PA51160055 PA51160056 PA51160057 PA51160058 PA51160059 PA51160060 PA14170880 PA14170881 PA14170882 PA14170883 PA14170884 PA14170885 PA14170886 PA14170887 PA14170888 PA14170889 PA14170890 PA14170891 PA14170892 PA14170893 PA14170894 PA14170896 PA14170898 PA14170899 PA14170900 PA14170901 PA14170902 PA14170904 PA14170905 PA14170906 PA14170907 PA14170908 PA14170909 PA14170910 PA14170911 PA14170912 PA14170913 PA14170914 PA14170915 PA14170916 PA14170917 PA14170918 PA14170919 PA14170920 PA14170921 PA14170922 PA14170923 PA14170924 PA14170925 PA14170926 PA14170927 PA14170928 PA14170929 PA14170931 PA14170932 PA14170933 PA14170934 PA14170935 PA14170936 PA14170938 PA14170939 PA14170940 PA14170941 PA14170942 PA14170943 PA14170945 PA14170946 PA14170947 PA14170948 PA14170949 PA14170950 PA14170951 PA14170953 PA14170955 PA14170957 PA14170958 PA14170959 PA14170960 PA18171381 PA18171421 PA18171444 PA18171449 PA18171450 PA18171451 PA18171452 PA18171453 PA18171454 PA18171455 PA18171456 PA18171457 PA18171458 PA18171459 PA18171460 PA18171461 PA18171462 PA18171463 PA18171464 PA18171465 PA18171466 PA18171467 PA18171469 PA18171470 PA18171471 PA18171472 PA18171473 PA18171474 PA18171475 PA18171476 PA18171477 PA18171478 PA18171479 PA18171481 PA18171482 PA18171483 PA18171484 PA18171485 PA18171486 PA18171487 PA18171488 PA18171489 PA18171490 PA18171491 PA18171492 PA18171493 PA18171494 PA18171495 PA18171496 PA18171497 PA18171498 PA18171499 PA18171500 PA19171501 PA19171502 PA19171503 PA19171504 PA19171505 PA19171506 PA19171507 PA19171508…
FDA’s list runs to 7,655 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.
The products were distributed US nationwide and Puerto Rico. The products were distributed to the following foreign countries: Argentina, Australia, Austria, Bahrain, Belgium, Canada, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Mexico, Netherlands, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, UAE, UK, and Vietnam.
The states and territories these words name
- Puerto Rico
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 Jul 31, 2018.
- FDA classified it on Oct 3, 2018.
- FDA’s Enforcement Report published it on Oct 10, 2018.
- FDA terminated it on Sep 20, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Oridion Medical 1987 Ltd., of Jerusalem, Israel.
- 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 7,655 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.