Carestation 620 A2 — Class II medical device recall Z-0580-2018
Ongoing recall by GE Medical Systems China Co., Ltd., reported 2018-02-21, distributed in AL, AR, AZ, CA, CO, CT, DC, DE…. Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Ca
| Recall number | Z-0580-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems China Co., Ltd., Wuxi, China |
| Recall initiated | 2017-10-11 |
| Classified | 2018-02-09 |
| Reported by FDA | 2018-02-21 |
| Distributed | 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, PR, TN, TX, UT, VA, VT, WA, WI, WV |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IT, JM, JO, JP, KE, KR, KW, LB, LT, LV, MA, MT, MX, MY, NG, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, RO, RS, RU, SA, SE, SG, SI, SK, SV, TH, TR, TW, UY, VE, VN, ZA |
| Quantity | 5,148 devices |
| Reason classes | packaging |
| Serial numbers | SM617230002WA, SM617230003WA, SM617230006WA, SM617230066WA, SM617230067WA, SM617230068WA, SM617230069WA, SM617230070WA, SM617230071WA, SM617230072WA, SM617230073WA, SM617230074WA, SM617230075WA, SM617230076WA, SM617230077WA, SM617230078WA, SM617230079WA, SM617230080WA, SM617230081WA, SM617240003WA-A2, SM617240004WA-A2, SM617240005WA, SM617240006WA, SM617240007WA, SM617240008WA and 158 more |
| Model numbers | 1012-9620-000, 1012-9620-002, 1012-9650-000, 1012-9650-002, 1012-9655-000, 1012-9655-002 |
Product
Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2
Reason for recall
Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems.
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-0580-2018. 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.