CARESCAPE Respiratory Module E-sCAiOV
Medical device recall Z-0757-2020. 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
- 37 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-sCAiOV
37 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 # SGV19283064HA 010084068210414221SGV19283064HA11190710 SGV19283042HA 010084068210414221SGV19283042HA11190710 SGV19243024HA 010084068210414221SGV19243024HA11190610 SGV19283053HA…
Every code shown here, 1,999 characters
Mfg. Lot or Serial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ot Applicable
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.”
- 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.