Getinge Usa Sales Inc: Medical Device Recall in 2023 - (Recall #: Z-0959-2023)

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-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400

Product Classification:

Class I

Date Initiated: December 22, 2022

Date Posted: February 1, 2023

Recall Number: Z-0959-2023

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 6677200 7325710001349 Serial Numbers 1202-8027 Part # UDI 6677300 7325710001363 Serial Numbers 1058-1201 Part # UDI 6677400 7325710001318 Serial Numbers 2034-8446 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