Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation…
Medical device recall Z-0813-2020. Published in FDA’s Enforcement Report on Jan 29, 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 29, 2020. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 3319 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?
GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would cause a loss of mechanical ventilation and the system will provide high priority audio and visual alarms. Loss of mechanical ventilation could lead to hypoxia if the clinician does not intervene.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.
3319 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
CARESTATION 620 A1, Model Number 1012-9620-000 Mfg. Lot or Serial # UDI # SM619130003MA 010084068210398521SM619130003MA11190326 SM619120026MA 010084068210398521SM619120026MA11190321 SM619030025MA 010084068210398521SM619030025MA11190117…
Every code shown here, 1,978 characters
CARESTATION 620 A1, Model Number 1012-9620-000 Mfg. Lot or Serial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…
FDA’s list runs to 179,509 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.
Worldwide Distribution: US (Nationwide) and countries of: Albania, Algeria, Argentina, Australia, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Croatia and Hrvatska, Czech Republic, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Maldives, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, Oman, Paraguay, Peru, Philippines, Poland, Portugal, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Viet Nam.
These words name no state.
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 Nov 25, 2019.
- FDA classified it on Jan 23, 2020.
- FDA’s Enforcement Report published it on Jan 29, 2020.
- FDA terminated it on Nov 30, 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 179,509 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.