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).
FDA Recall Z-1562-2016 · Posted None
Recalling FirmGE Medical Systems, LLC
Recall StatusTerminated
Product CodeBSZ
Date Initiated2016-03-15
Date Terminated2016-11-07
Product Quantity952 (488 US; 464 OUS)
Reason for Recall
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.
Firm 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 customers to arrange for the correction at no cost to the customer. For questions or concerns regarding this notification, contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Root Cause
Employee error
Distribution Pattern
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, KAZAKHSTAN, KOREA, KUWAIT, NETHERLANDS, NEW ZEALAND, SAUDI ARABIA, SPAIN, SWITZERLAND, THAILAND, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.