Carestation 620 A1 — Class II medical device recall Z-2703-2017
Terminated recall by GE Healthcare, LLC, reported 2017-07-19, distributed in AL, AR, AZ, CA, CO, CT, FL, GA…. Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction
| Recall number | Z-2703-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2017-05-02 |
| Classified | 2017-07-07 |
| Reported by FDA | 2017-07-19 |
| Terminated | 2018-02-13 |
| Distributed | AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, PR, TN, TX, UT, VA, WA, WI |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BO, BR, CA, CH, CL, CO, CR, CZ, DE, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IT, JO, JP, KE, KR, KW, LB, LT, LV, MA, MT, MX, MY, NG, NL, NO, NZ, OM, PE, PH, PK, PL, PT, PY, RO, RS, RU, SA, SE, SG, SI, SK, SV, TH, TR, TW, UY, VN, ZA |
| Reason classes | device malfunction |
Product
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
Reason for recall
Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2703-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.