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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

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
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: 1-200-0350 with Kit Number: 4-000-0722
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: 1-200-0350; UDI-DI: 00841709105821; Kit No: 4-000-0722; UDI-DI: 00841709105906; Kit Serial Number: V2866143 V2866111 V2866124 V2864892 V2864113 V2864444 V2864120 V2864449 V2864894 V2866626 V2866636 V2871280 V2870561 V2869170 V2870570 V2869930 V2874364 V2897744 V2900961 V2900947; Zone Serial Number: V2864929 V2865546 V2864921 V2864495 V2796056 V2864174 V2858651 V2864142 V2873819 V2866216 V2866187 V2870249 V2870090 V2867500 V2866707 V2869394 V2873111 V2886635 V2873150 V2886126
Product quantity
20 units
Voluntary mandated
Voluntary: Firm initiated
City
Versailles
State
OH
Country
United States
Event id
99641
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