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Midmark Corporation: Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), a

Medical DevicesSource: FDA (device) · Date: 2026-09-30

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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
Midmark Corporation
Product
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-0320 with Kit Number: 4-000-0622
Reason / hazard
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution.
Recall initiated
2026-08-21
Code info
Model No: 1-200-0320; UDI-DI: 00841709105791; Kit No: 4-000-0622; UDI-DI: 00841709105876; Kit Serial Number: V2900924; Zone Serial Number: V2899738
Product quantity
1 units
Voluntary mandated
Voluntary: Firm initiated
City
Versailles
State
OH
Country
United States
Event id
99641
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