CARESCAPE Respiratory Module E-sCAiO
Medical device recall Z-0756-2020. Published in FDA’s Enforcement Report on Jan 22, 2020.
- 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 Jan 22, 2020. 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
- 161 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?
Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
CARESCAPE Respiratory Module E-sCAiO
161 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Mfg. Lot or Serial # UDI # SGV19240073HA 010084068210418021SGV19240073HA11190611 SGV19280017HA 010084068210418021SGV19280017HA11190708 SGV18150053HA 010084068210418021SGV18150053HA11180411 SGV19240172HA…
Every code shown here, 1,985 characters
Mfg. Lot or Serial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…
FDA’s list runs to 8,545 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.
US OUS: Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Korea (Republic of), Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Peru, Poland, Republic of Serbia, Romania, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, and Unites Kingdom
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 Sep 27, 2019.
- FDA classified it on Jan 10, 2020.
- FDA’s Enforcement Report published it on Jan 22, 2020.
- FDA terminated it on Sep 26, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, LLC, of Waukesha, WI.
- 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 8,545 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.