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Hamilton Medical AG: IntelliCuff, Portable automatic cuff pressure controller REF: 951001

Medical DevicesSource: FDA (device) · Date: 2026-07-08

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Hamilton Medical AG
Product
IntelliCuff, Portable automatic cuff pressure controller REF: 951001
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2026-05-22
Code info
GTIN: 07630002800839/ Lot # range: 00001 -19732
Product quantity
962 units
Voluntary mandated
Voluntary: Firm initiated
City
Domat/Ems
State
N/A
Country
Switzerland
Event id
99035
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