Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
Medical device recall Z-0579-2018. 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 A1, Carestation 650 A1, and Carestation 650c A1
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 Numbers: SM617100166MA SM617100163MA SM617100164MA SM617100165MA SM617100167MA SM617100168MA SM616460036MA SM616460037MA…
Every code shown here, 1,992 characters
Model No. 1012-9620-000, 1012-9650-000, 1012-9655-000, 1012-9650-002, 1012-9620-002, 1012-9655-002; Serial Numbers: SM617100166MA SM617100163MA SM617100164MA SM617100165MA SM617100167MA SM617100168MA SM616460036MA SM616460037MA SM717200075MA SM717200072MA SM717200073MA SM717200074MA SM617300054MA SM716390006MA SM716390007MA SM716390008MA SM717020018MA SM717020019MA SM717020020MA SM717020021MA SM717020022MA SM717020023MA SM717020024MA SM717020025MA SM717200052MA SM716300041MA SM716300040MA SM716300031MA SM716480059MA SM716480060MA SM716510010MA SM716510011MA SM716510012MA SM716510013MA SM716510014MA SM616400001MA SM716380022MA SM716380023MA SM716380024MA SM616250007MA SM616460048MA SM616460049MA SM617240035MA SM617240034MA SM617170052MA SM716480021MA SM716480022MA SM716480023MA SM716480024MA SM716480025MA SM716480026MA SM716480027MA SM716480028MA SM616460022MA SM717020026MA SM717020027MA SM717020028MA SM717020029MA SM717020030MA SM616250005MA SM616400004MA SM616400005MA SM617110011MA SM617110012MA SM617110013MA SM617110014MA SM717200055MA SM717320026MA SM617310035MA SM617310032MA SM617310033MA SM617310034MA SM716510015MA SM716510016MA SM716510017MA SM717020040MA SM716300024MA SM716300025MA SM716300026MA SM716430052MA SM716430053MA SM716430054MA SM716430055MA SM717150063MA SM716480057MA SM616250001MA SM616250002MA SM616250003MA SM616250004MA SM617240031MA SM617240030MA SM717200058MA SM617340015MA SM617340013MA SM617340014MA SM617180039MA SM617180038MA SM617180042MA SM617180041MA SM617310038MA SM716480029MA SM716480030MA SM716480031MA SM716480032MA SM716480033MA SM616200020MA SM617310037MA SM617310036MA SM617310040MA SM617310039MA SM717150034MA SM717150033MA SM717150035MA SM717150036MA SM717150037MA SM717150038MA SM717150039MA SM717150047MA SM717150040MA SM717150041MA SM717150042MA SM717150043MA SM717150046MA SM717150044MA SM717150045MA SM717150048MA SM717150049MA SM717150050MA SM717150051MA SM717150052MA SM717150053MA SM717150054MA SM717150055MA SM616200019MA…
FDA’s list runs to 260,745 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 260,745 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.