Recall Z-0579-2018 ยท BSZ Gas-Machine, Anesthesia
GE Medical Systems China Co., Ltd.
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
| Date | Oct 11, 2017 |
| Status | Open, Classified |
| Reason | Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems. |
| Root cause | Other |
| Action | On approximately 10/11/2017 customers were notified of the recall via letter. Instructions include that if elevated FiCO2 is observed, to increase the flow of fresh gas to reduce the volume of patient gas that is rebreathed. If the FiCO2 cannot be adequately reduced with this action, consider switching to another anesthesia delivery device. GE Healthcare is planning to release revised parts that minimize the likelihood of incomplete gas flow through the CO2 absorbent canister. GE Healthcare will correct all affected devices by installing updated parts at no cost to the customer. The upd |
| Quantity | 5,148 devices |
| Distribution | 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, Boli |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151570 | Carestation 620/650/650C Datex-Ohmeda, Inc., Jan 21, 2016 |