Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to provide general inhalation…
Medical device recall Z-0814-2020. 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
- 280 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 A2 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.
280 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
CARESTATION 620 A2, Model number 1012-9620-002, No UDI, OUS only Mfg. Lot or Serial # SM618370003WA SM618370004WA SM618370005WA SM618370006WA SM618370010WA SM618370070WA SM618370071WA SM618380001WA SM618380002WA SM618380008WA SM618380009WA…
Every code shown here, 1,990 characters
CARESTATION 620 A2, Model number 1012-9620-002, No UDI, OUS only Mfg. Lot or Serial # SM618370003WA SM618370004WA SM618370005WA SM618370006WA SM618370010WA SM618370070WA SM618370071WA SM618380001WA SM618380002WA SM618380008WA SM618380009WA SM618380010WA SM618380011WA SM618450033WA SM618480061WA SM618500014WA SM619110035WA SM618360022WA SM618360027WA SM618360028WA SM618370020WA SM618370021WA SM618370022WA SM618370023WA SM618370051WA SM618370052WA SM618370053WA SM618370056WA SM618360007WA SM619030013WA SM619030014WA SM619030015WA SM619030016WA SM619040001WA SM619150001WA SM618430007WA SM618440004WA SM618480064WA SM618390031WA SM619100010WA SM618420021WA SM618420022WA SM618420023WA SM618420024WA SM618480063WA SM619070003WA SM619170051WA SM618460048WA SM619070001WA SM619070002WA SM618410001WA SM618410002WA SM618500015WA SM618450034WA SM618380007WA SM619030007WA SM619110044WA SM619120001WA SM619135003WA SM618440035WA SM619110011WA SM618360011WA SM618450013WA SM619090011WA SM618460062WA SM618350016WA SM618460049WA SM618460050WA SM618460051WA SM618480036WA SM618380017WA SM618380018WA SM618500004WA SM618500005WA SM618430008WA SM618450012WA SM618490017WA SM618490018WA SM619030012WA SM619135004WA SM618380014WA SM618370073WA SM619120002WA SM619120003WA SM619120004WA SM618430005WA SM618490010WA SM618490013WA SM618490014WA SM618380020WA SM618500001WA SM618500002WA SM618360009WA SM618360013WA SM618370024WA SM618500016WA SM618500017WA SM618500018WA SM618500019WA SM618500020WA SM618500021WA SM618380003WA SM618380004WA SM618370072WA SM618370074WA SM618490015WA SM618490016WA SM618490019WA SM618490020WA SM618490025WA SM618490026WA SM618500003WA SM618370014WA SM618370015WA SM618370016WA SM618370017WA SM618370018WA SM618370019WA SM618370013WA SM619080002WA SM618420020WA SM619080022WA SM618510004WA SM618510005WA SM618510006WA SM619020020WA SM619090008WA SM619090009WA SM619090010WA SM619090012WA SM619090013WA SM618370054WA SM618390009WA SM618390010WA SM619110002WA SM619110003WA…
FDA’s list runs to 4,178 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 4,178 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.