GE Healthcare, LLC: Medical Device Recall in 2022 - (Recall #: Z-1427-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.

Product Classification:

Class II

Date Initiated: May 27, 2022

Date Posted: July 27, 2022

Recall Number: Z-1427-2022

Event ID: 90422

Reason for Recall:

The base of the anesthesia system can have a crack and could potentially fracture resulting in a tip or overbalance of the anesthesia system. This can result in potential injury if it falls on a person.

Status: Ongoing

Product Quantity: 667 devices

Code Information:

Avance CS2 and Avance CS2 Pro - GTIN 00840682102322, all serial numbers; Aisys CS2 - GTIN 00840682102292, all serial numbers.

Distribution Pattern:

Distribution was made to AZ, CA, CO, CT, FL, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MO, MT, NC, NE, NV, NY, OH, PA, SC, TN, TX, VA, and WV. There was also military distribution but no government distribution. Foreign distribution was made to Australia, Canada, China, Estonia, Finland, France, Germany, Greece, India, Indonesia, Iraq, Ireland, Italy, Japan, Jordan, Kenya, Korea, Malaysia, New Zealand, Philippines, Romania, Russia, Saudi Arabia, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated