Getinge Usa Sales Inc: Medical Device Recall in 2024 - (Recall #: Z-0991-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Flow-e Anesthesia System, model 6887900

Product Classification:

Class II

Date Initiated: December 11, 2023

Date Posted: February 14, 2024

Recall Number: Z-0991-2024

Event ID: 93736

Reason for Recall:

Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous situation.

Status: Ongoing

Product Quantity: 86 (US)

Code Information:

UDI-DI: 07325710010457, serial numbers (US): 50012, 50030, 50031, 50033, 50034, 50035, 50036, 50037, 50038, 50039, 50040, 50041, 50042, 50043, 50046, 50047, 50048, 50051, 50052, 50053, 50054, 50055, 50056, 50057, 50058, 50059, 50060, 50069, 50070, 50071, 50072, 50073, 50074, 50084, 50085, 50086, 50087, 50088, 50089, 50090, 50091, 50092, 50093, 50094, 50096, 50097, 50108, 50109, 50110, 50111, 50132, 50154, 50155, 50193, 50194, 50195, 50196, 50197, 50199, 50211, 50212, 50213, 50214, 50215, 50216, 50217, 50218, 50219, 50220, 50221, 50223, 50224, 50225, 50244, 50245, 50246, 50247, 50248, 50249, 50250, 50251, 50252, 50253, 50254, 50276, 50277.

Distribution Pattern:

Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, DC, FL, GA, IN, MA, MI, MO, NY, OH, OR, PA, TX, VA, WA & WV.

Voluntary or Mandated:

Voluntary: Firm initiated