Class II — GE Healthcare, LLC
| Recalling firm | GE HealthCare Technologies Inc. |
|---|---|
| Registered facility | View this company's 50 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction |
| Product | Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1 |
| Quantity | 3,448 (334 US; 3,114 OUS) |
| Distribution | 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 Ecua… |
| Initiated | 2017-05-02 |
| Classified | 2017-07-07 |
| Terminated | 2018-02-13 |
| Recall number | Z-2703-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — GE Healthcare, LLC (Z-2703-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77244/
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