Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

GE Healthcare Recalled by GE Medical Systems, LLC Due to The vacuum suction tubing could be kinked within...

Date: March 15, 2016
Company: GE Medical Systems, LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact GE Medical Systems, LLC directly.

Affected Products

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).

Quantity: 952 (488 US; 464 OUS)

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 26 states: AZ, CA, FL, GA, ID, IL, IN, KY, MD, MI, MN, MO, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, DC

Affected (26 states)Not affected

About GE Medical Systems, LLC

GE Medical Systems, LLC has 146 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report