FDA-Device2026-07-08Class II

IntelliCuff, Portable automatic cuff pressure controller REF: 951001

Hazard

Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user.

Sold states

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, IL, KY, MA, MI, ND, NE, NE, NY, OH, PA, PR, SD, TX, VA, WA, WI, WV, WY and the country of Canada.

Affected count

962 units

Manufactured in

Parc Industrial Vial 10, N/A, Domat/Ems, N/A, Switzerland

Products

IntelliCuff, Portable automatic cuff pressure controller REF: 951001

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2625-2026

More Hamilton Medical AG recalls

FDA-Device2026-07-08
Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.

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