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Flow-c Anesthesia System, model 6887700

FDA Recall #Z-0990-2024 — Class II — December 11, 2023

Recall #Z-0990-2024 Date: December 11, 2023 Classification: Class II Status: Ongoing

Product Description

Flow-c Anesthesia System, model 6887700

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.

Recalling Firm

Getinge Usa Sales Inc — Wayne, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

14 (US)

Distribution

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.

Code Information

UDI-DI: 07325710009765, serial numbers (US): 5024, 5025, 5026, 5027, 5028, 5043, 5044, 5045, 5046, 5047, 5048, 5049, 5050, 5078.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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