Recall Z-1376-2015 ยท BSZ Gas-Machine, Anesthesia
GE Healthcare
GE Healthcare, Aespire 7900, Aespire View Anesthesia Machines. Model numbers 1009-9012-000. Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients
| Date | Apr 2, 2015 (initiated Feb 27, 2015) |
| Status | Terminated |
| Reason | Specific Aespire 7900 Anesthesia Machines have an increased likelihood of failure of the CPU circuit board. This could result in a blank display or loss of mechanical ventilation. |
| Root cause | Process control |
| Action | Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 34064, dated February 27, 2015. The letter was addressed to Chief of Anesthesia, Health Care Administrator / Risk Manager and Director of Biomedical / Clinical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The letter stated that customers can continue to use the affected device in Manual Ventilation mode, and contact their local GE Healthcare Service Representative. GE Healthcare will correct all affected |
| Quantity | 46 (10 units US, 36 units OUS) |
| Distribution | Worldwide Distribution -- US, including the states of NC and OK; and the countries of CHINA, INDIA, JAPAN, MEXICO, and VENEZUELA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122445 | AESPIRE 7900, AESPIRE VIEW Datex-Ohmeda, Oct 12, 2012 |