Getinge Usa Sales Inc: Medical Device Recall in 2023 - (Recall #: Z-0961-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Getinge Flow-e Anesthesia System, Part No. 6887900

Product Classification:

Class I

Date Initiated: December 22, 2022

Date Posted: February 1, 2023

Recall Number: Z-0961-2023

Event ID: 91339

Reason for Recall:

Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hypoventilation and hypoxia.

Status: Ongoing

Product Quantity: 8.016 Total (7.766 OUS; 250 US)

Code Information:

Part # UDI 6887900 07325710010457 Serial Numbers 50012-50197 Software versions 4.8.0, 4.8.1, 4.8.2, and 4.8.3.

Distribution Pattern:

US nationwide and Worldwide Distribution: Domestic distribution to AL, AR, AZ, CA, CO, DC, FL, GA, IN, MA, MI, MO, NY, OH, OR, PA, TX, VA, WA, WV. Foreign distribution worldwide.

Voluntary or Mandated:

Voluntary: Firm initiated