Carestation 620/650/650c A2 Product Usage: anesthesia systems are… — Class I medical device recall Z-0814-2020
Terminated recall by GE Healthcare, LLC, reported 2020-01-29, distributed nationwide. GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufact
| Recall number | Z-0814-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2019-11-25 |
| Classified | 2020-01-23 |
| Reported by FDA | 2020-01-29 |
| Terminated | 2023-11-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BD, BE, BH, BO, BR, CA, CH, CL, CN, CO, CZ, DE, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IL, IN, IQ, IT, JM, JO, JP, KE, KR, KW, LB, LT, LV, MX, MY, NG, NL, NP, NZ, OM, PE, PH, PL, PT, PY, RS, SA, SE, SG, SI, SK, TH, TN, TR, TW, UY, VN, ZA |
| Quantity | 280 units |
| Serial numbers | SM618340078WA, SM618350016WA, SM618360007WA, SM618360008WA, SM618360009WA, SM618360010WA, SM618360011WA, SM618360012WA, SM618360013WA, SM618360022WA, SM618360027WA, SM618360028WA, SM618360029WA, SM618360030WA, SM618370001WA, SM618370002WA, SM618370003WA, SM618370004WA, SM618370005WA, SM618370006WA, SM618370010WA, SM618370012WA, SM618370013WA, SM618370014WA, SM618370015WA and 255 more |
| Model numbers | 1012-9620-002, 1012-9650-002, 1012-9655-002 |
Product
Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.
Reason for recall
GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would cause a loss of mechanical ventilation and the system will provide high priority audio and visual alarms. Loss of mechanical ventilation could lead to hypoxia if the clinician does not intervene.
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-0814-2020. 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.