Recall Z-2703-2017 ยท BSZ Gas-Machine, Anesthesia
GE Healthcare, LLC
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
| Date | May 24, 2017 (initiated May 2, 2017) |
| Status | Terminated |
| Reason | Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction |
| Root cause | Device Design |
| Action | Consignees were sent on 5/2/2017 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 34082 dated May 2, 2017. The letter was addressed to Chief of Anesthesia, Director of Biomedical / Clinical Engineering & Health Care Administrator / Risk Manager. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction & Contact Information. GE Healthcare will correct affected products. GE Healthcare representative will contact the firms to arrange for the correction. For questions contact GE Healthcare Service at 1-800-437-1171 or your local |
| 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 B |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151570 | Carestation 620/650/650C Datex-Ohmeda, Inc., Jan 21, 2016 |