Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
Medical device recall Z-2703-2017. Published in FDA’s Enforcement Report on Jul 19, 2017.
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 Jul 19, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 35 states named in where it went
- 3,448 (334 US; 3,114 OUS) 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?
Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction
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
3,448 (334 US; 3,114 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Carestation 620 A1: SM616460036MA SM616460037MA SM616400001MA SM616250007MA SM616340023MA SM616460048MA SM616460049MA SM616460022MA SM616250005MA SM616400004MA SM616400005MA SM617110011MA SM617110012MA SM617110013MA SM617110014MA…
Every code shown here, 1,994 characters
Carestation 620 A1: SM616460036MA SM616460037MA SM616400001MA SM616250007MA SM616340023MA SM616460048MA SM616460049MA SM616460022MA SM616250005MA SM616400004MA SM616400005MA SM617110011MA SM617110012MA SM617110013MA SM617110014MA SM616430024MA SM616200020MA SM616200019MA SM616200021MA SM616200022MA SM616200023MA SM616200024MA SM617010108MA SM616270021MA SM616270022MA SM617020019MA SM617020020MA SM617020021MA SM616460047MA SM616340001MA SM616340002MA SM616340039MA SM616340025MA SM616460052MA SM616460053MA SM616460054MA SM616460055MA SM616460056MA SM616460057MA SM616250006MA SM616460035MA SM617010114MA SM617010115MA SM617010116MA SM617010117MA SM617010118MA SM616340027MA SM616410061MA SM616340018MA SM616340019MA SM616340020MA SM616460030MA SM616460028MA SM616460029MA SM616410043MA SM617020010MA SM617020011MA SM617020012MA SM617020013MA SM617020014MA SM617020015MA SM617020016MA SM617020017MA SM617020018MA SM617060084MA SM617100056MA SM617100057MA SM616400016MA SM616400017MA SM616170021MA SM616170022MA SM616200012MA SM616340028MA SM616340029MA SM616340030MA SM617100058MA SM616340021MA SM616430034MA SM616430035MA SM617100157MA SM616250001MA SM616250002MA SM616250003MA SM616250004MA SM617100019MA SM617100020MA SM617100021MA SM617100022MA SM617100023MA SM617100024MA SM617100025MA SM617020026MA SM616100020MA SM616100021MA SM616100022MA SM616100023MA SM616100024MA SM616200013MA SM616200016MA SM616200014MA SM616200015MA SM617020007MA SM617020008MA SM617020009MA SM615500007WA SM616150007WA SM616220004WA SM616220005WA SM616220006WA SM616370002WA SM616370003WA SM616370005WA SM616370006WA SM616450003WA SM617030015WA SM617030016WA SM617030017WA SM617040018WA SM617040019WA SM617040020WA SM617040021WA SM617040022WA SM617040023WA SM617060001WA SM617060002WA SM617060003WA SM617060004WA SM617120006WA SM617120007WA SM617080015WA SM617080016WA SM617080017WA SM617080018WA SM617080019WA SM617080020WA SM617080021WA SM617080022WA SM616400019MA SM616400020MA SM616460023MA SM616460024MA…
FDA’s list runs to 48,333 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.
US Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL GA, ID,IL, IN, KY, LA, , MA, MD, MI, MO, MS, MT, MN, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, VA, WA, WI, and UT. OUS: Algeria Argentina Australia Austria Belgium Bolivia Bosnia and Herzegovina Brazil Bulgaria Cambodia Canada Chile Colombia Costa Rica Cote d’Ivoire Croatia Czech Republic Ecuador Egypt El Salvador Estonia Finland France Germany Greece Honduras Hong Kong Hungary India Indonesia Iraq Ireland Israel Italy 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 Paraguay Peru Philippines Poland Portugal Romania Russia Saudi Arabia Senegal Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Tanzania Thailand Turkey United Arab Emirates United Kingdom Uruguay Vietnam Zimbabwe
The states and territories these words name
35 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- 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
- Puerto Rico
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
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 May 2, 2017.
- FDA classified it on Jul 7, 2017.
- FDA’s Enforcement Report published it on Jul 19, 2017.
- FDA terminated it on Feb 13, 2018.
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 48,333 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.