Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2
Medical device recall Z-0580-2018. Published in FDA’s Enforcement Report on Feb 21, 2018.
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 Feb 21, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 38 states named in where it went
- 5,148 devices 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 II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2
5,148 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model No. 1012-9620-000, 1012-9650-000, 1012-9655-000, 1012-9650-002, 1012-9620-002, 1012-9655-002; Serial No. SM617240023WA-A2, SM617240022WA-A2 SM617250011WA-A2 SM617240010WA-A2 SM617240011WA-A2 SM617240003WA-A2 SM617240012WA-A2…
Every code shown here, 1,988 characters
Model No. 1012-9620-000, 1012-9650-000, 1012-9655-000, 1012-9650-002, 1012-9620-002, 1012-9655-002; Serial No. SM617240023WA-A2, SM617240022WA-A2 SM617250011WA-A2 SM617240010WA-A2 SM617240011WA-A2 SM617240003WA-A2 SM617240012WA-A2 SM617240004WA-A2 SM717180002WA-A2 SM717250002WA-A2 SM717230002WA-A2 SM717250003WA-A2 SM717250011WA-A2 SM717250010WA-A2 SM817240005WA SM817240003WA SM817240004WA SM617230006WA SM617230066WA SM617230067WA SM617230068WA SM617230069WA SM617230070WA SM617230071WA SM617230072WA SM617230073WA SM617230074WA SM617230075WA SM617230076WA SM617230077WA SM617230079WA SM617230078WA SM617250041WA SM617250040WA SM617230081WA SM617230080WA SM617240009WA SM617240019WA SM617240016WA SM617240017WA SM617240018WA SM617240024WA SM617250012WA SM617250009WA SM617250005WA SM617250003WA SM617250019WA SM617250004WA SM617250010WA SM617250023WA SM617250022WA SM617250024WA SM617250028WA SM617250025WA SM617250026WA SM617250027WA SM617250029WA SM617250030WA SM617250031WA SM617250032WA SM617250033WA SM617250034WA SM617250038WA SM617250035WA SM617250039WA SM617250036WA SM617250037WA SM617320008WA SM617330010WA SM617330009WA SM617370027WA SM617230003WA SM617230002WA SM617250016WA SM617250013WA SM617250014WA SM617250015WA SM617250017WA SM617250020WA SM617250002WA SM617250001WA SM617360038WA SM617380014WA SM617250018WA SM617370028WA SM617240008WA SM617240005WA SM617240006WA SM617240007WA SM617280005WA SM617330008WA SM617330006WA SM617330007WA SM617370016WA SM617370087WA SM617370084WA SM617370085WA SM617370086WA SM617370088WA SM617370018WA SM617370017WA SM617370015WA SM617370008WA SM617250021WA SM617280015WA SM617280014WA SM617280016WA SM617280018WA SM617280022WA SM617280019WA SM617280020WA SM617280021WA SM617280023WA SM617280024WA SM617280025WA SM617280026WA SM617280027WA SM617280028WA SM617280029WA SM617280030WA SM617280031WA SM617280032WA SM617280033WA SM617290005WA SM617290006WA SM617290007WA SM617290008WA SM617280017WA SM617330023WA SM617370006WA SM617370004WA…
FDA’s list runs to 3,093 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.
Distributed domestically to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, VT, WA, WI, WV. Distributed internationally to Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote Di’Viore, Croatia, Czech Republic, Democratic Republic of Congo, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Maldives, Malta, Mauritius, Mexico, Moldova, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Zimbabwe.
The states and territories these words name
38 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Idaho
- Illinois
- Indiana
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- New Hampshire
- New Jersey
- Nevada
- New York
- Ohio
- Oklahoma
- Pennsylvania
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Oct 11, 2017.
- FDA classified it on Feb 9, 2018.
- FDA’s Enforcement Report published it on Feb 21, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Medical Systems China Co., Ltd., of Wuxi, China.
- 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 3,093 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
-
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.