Recall Z-1382-2016 · BSZ Gas-Machine, Anesthesia
GE Medical Systems, LLC
GE Healthcare, Aisys Carestation.
| Date | Feb 17, 2016 |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all Aisys CS2 and upgraded Aisys anesthesia devices. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were sent on 2/17/2016 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 34075 dated February 17, 2016.The letter was addressed to Chief of Anesthesia, Director of Biomedical / Clinical Engineering, and Health Care Administrator / Risk Manager. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. |
| Quantity | 1294 |
| Distribution | US: AL, AZ, AR, CA, CO, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE, NV, NJ, NY, NC, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI. OUS: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, CANDA, CHILE, CHINA, COLOMBIA, CROATIA, CR¿CHE REPU |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110213 | GE DATEX-OHMEDA AISYS Datex-Ohmeda, Inc., Jul 20, 2011 |