Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2
FDA Device Recall #Z-0580-2018 — Class II — October 11, 2017
Recall Summary
| Recall Number | Z-0580-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 11, 2017 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Medical Systems China Co., Ltd. |
| Location | Wuxi |
| Product Type | Devices |
| Quantity | 5,148 devices |
Product Description
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.
Distribution Pattern
Distributed domestically to 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, TN, TX, UT, VA, VT, WA, WI, WV. Distributed internationally to Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote Di'Viore, Croatia, Czech Republic, Democratic Republic of Congo, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, 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, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Zimbabwe.
Lot / Code Information
Model No. 1012-9620-000, 1012-9650-000, 1012-9655-000, 1012-9650-002, 1012-9620-002, 1012-9655-002; Serial No. SM617240023WA-A2, SM617240022WA-A2 SM617250011WA-A2 SM617240010WA-A2 SM617240011WA-A2 SM617240003WA-A2 SM617240012WA-A2 SM617240004WA-A2 SM717180002WA-A2 SM717250002WA-A2 SM717230002WA-A2 SM717250003WA-A2 SM717250011WA-A2 SM717250010WA-A2 SM817240005WA SM817240003WA SM817240004WA SM617230006WA SM617230066WA SM617230067WA SM617230068WA SM617230069WA SM617230070WA SM617230071WA SM617230072WA SM617230073WA SM617230074WA SM617230075WA SM617230076WA SM617230077WA SM617230079WA SM617230078WA SM617250041WA SM617250040WA SM617230081WA SM617230080WA SM617240009WA SM617240019WA SM617240016WA SM617240017WA SM617240018WA SM617240024WA SM617250012WA SM617250009WA SM617250005WA SM617250003WA SM617250019WA SM617250004WA SM617250010WA SM617250023WA SM617250022WA SM617250024WA SM617250028WA SM617250025WA SM617250026WA SM617250027WA SM617250029WA SM617250030WA SM617250031WA SM617250032WA SM617250033WA SM617250034WA SM617250038WA SM617250035WA SM617250039WA SM617250036WA SM617250037WA SM617320008WA SM617330010WA SM617330009WA SM617370027WA SM617230003WA SM617230002WA SM617250016WA SM617250013WA SM617250014WA SM617250015WA SM617250017WA SM617250020WA SM617250002WA SM617250001WA SM617360038WA SM617380014WA SM617250018WA SM617370028WA SM617240008WA SM617240005WA SM617240006WA SM617240007WA SM617280005WA SM617330008WA SM617330006WA SM617330007WA SM617370016WA SM617370087WA SM617370084WA SM617370085WA SM617370086WA SM617370088WA SM617370018WA SM617370017WA SM617370015WA SM617370008WA SM617250021WA SM617280015WA SM617280014WA SM617280016WA SM617280018WA SM617280022WA SM617280019WA SM617280020WA SM617280021WA SM617280023WA SM617280024WA SM617280025WA SM617280026WA SM617280027WA SM617280028WA SM617280029WA SM617280030WA SM617280031WA SM617280032WA SM617280033WA SM617290005WA SM617290006WA SM617290007WA SM617290008WA SM617280017WA SM617330023WA SM617370006WA SM617370004WA SM617370005WA SM617360037WA SM617380004WA SM617380001WA SM617380002WA SM617380003WA SM617380005WA SM617380006WA SM617380007WA SM617380008WA SM617380009WA SM617360004WA SM617370007WA SM617370022WA SM617370019WA SM617370020WA SM617370021WA SM617370023WA SM617370024WA SM617370003WA SM617370001WA SM617370002WA SM617370012WA SM617370009WA SM617370010WA SM617370011WA SM617370013WA SM617370014WA SM617360040WA SM617380013WA SM717250005WA SM717250007WA SM717320001WA SM717230003WA SM717230005WA SM717230004WA SM717260002WA SM717260001WA SM717370004WA SM717370003WA SM717250006WA SM717370001WA SM717250016WA SM717250014WA SM717250015WA SM717250013WA SM717330008WA SM717370002WA SM717370018WA SM817210001WA SM817210002WA SM717330016WA; UDI No.: 010084068210398521SM617250012WA11170624, 010084068210398521SM617250003WA11170619, 010084068210398521SM617250004WA11170619, 010084068210398521SM617250010WA11170621, 010084068210398521SM617250013WA11170624, 010084068210394721SM717260002WA11170627, 010084068210394721SM717260001WA11170627, 010084068210395421SM817210001WA11170522, 010084068210395421SM817210002WA11170522
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Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.