CARESCAPE Respiratory Module E-sCAiOE
Medical device recall Z-0758-2020. 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
- 59 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-sCAiOE
59 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 # SGV19254028HA 010084068210413521SGV19254028HA11190618 SGV19274009HA 010084068210413521SGV19274009HA11190703 SGV19264036HA 010084068210413521SGV19264036HA11190626 SGV19264004HA…
Every code shown here, 1,985 characters
Mfg. Lot or Serial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…
FDA’s list runs to 3,137 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 3,137 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.