Recall Z-1635-2009 ยท BSZ Gas-Machine, Anesthesia
GE Healthcare
Datex-Ohmeda S/5 Anesthesia Delivery Unit Intended to provide general inhalation anaesthesia and ventilatory support to a wide range of patients. Intended for volume or pressure control, pressure support and synchronized intermittent mandatory (SIMV) ventilation modes.
| Date | Jul 30, 2009 (initiated Oct 30, 2008) |
| Status | Terminated |
| Reason | GE Healthcare has received reports of breathing circuit or tubing misconnections of the Anesthesia Delivery Unit (ADU), that may impact patient safety. |
| Root cause | Other |
| Action | A GE Healthcare "Urgent Medical Device Correction" letter was sent to consignees on 1/16/09. The letter was addressed to Health Care Administrator, Chief of Anesthesia and Director of Clinical Engineering. The letter described the Safety Issue; Affected Product Details; Safety Instructions, which include clinical personnel being properly trained on the correct connections of breathing circuit tubing and proper execution of System Checkout according to the ADU URMs; Product Correction and Contact Information. |
| Quantity | 6,621 |
| Distribution | USA including states of AL, AK, AZ, AR, CA, CO, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, WA, and WI and countries of Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Bosnia & Herzegovina, |
| FDA record | Open on fda.gov |