Recall Z-1562-2016 ยท BSZ Gas-Machine, Anesthesia
GE Medical Systems, LLC
GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation anesthesia and ventilator support to a wide range of patients (neonatal, pediatric, and adult).
| Date | Mar 15, 2016 |
| Status | Terminated |
| Reason | The vacuum suction tubing could be kinked within the machine resulting in suction less than the 20 lpm required by ISO 10079-3. This could result in inadequate suction performance to clear the airway and inadequate ventilation of the patient. |
| Root cause | Employee error |
| Action | Consignees were sent a GE Healthcare "Urgent Medical Device Correction" GEHC Ref# 34076 letter, dated March 15, 2016. The letter was addressed to the 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 states that users can continue to use all functions of the device. However, the vacuum suction option can only be used if it passes the evaluation. A GE representative will contact customer |
| Quantity | 952 (488 US; 464 OUS) |
| Distribution | Worldwide Distribution -- US, to the states of AZ, CA, DC, FL, GA, ID, IL IN, KY, MD, MI, MN, MO, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI; and, to the countries of AUSTRALIA, BELGIUM. BOLIVIA, CANADA, CHILE, DENMARK, FINLAND, FRANCE, GERMANY, HUNGARIA, INDIA, IRELAND, JAPAN, KAZAKHSTA |
| FDA record | Open on fda.gov |