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).

Recall Insight

This FDA Devices action (record #Z-1562-2016) was formally reported on May 4, 2016, with the manufacturer initiating the action on March 15, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Ge Medical Systems, LLC is listed as the recalling firm, operating out of Waukesha, WI. Federal records list the affected scope as 952 (488 US; 464 OUS).

The documented reason for this recall is: 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 vent… Distribution data in the federal record shows the product reached: 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, CHI…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.