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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: 1-200-0360 with Kit Number: 4-000-0724
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: 1-200-0360; UDI-DI: 00841709105838; Kit No: 4-000-0724; UDI-DI: 00841709105913; Kit Serial Number: V2788703 V2788046 V2788016 V2788712 V2789302 V2789846 V2789830 V2789837 V2789808 V2789303 V2789304 V2811103 V2811112 V2862288 V2862275 V2869139 V2866577 V2867451 V2869599 V2868801 V2869154 V2868545 V2866984 V2869980 V2869969 V2868130 V2867433 V2868182 V2924525 V2924566 V2924559 V2924539 V2927525; Zone Serial Number: V2788322 V2787552 V2787555 V2788321 V2788905 V2789498 V2787554 V2789488 V2789499 V2788922 V2787553 V2807891 V2807893 V2837260 V2859050 V2868888 V2862992 V2866942 V2868893 V2868239 V2868840 V2868222 V2866940 V2868892 V2869397 V2867491 V2866963 V2868051 V2923639 V2922999 V2922998 V2923640 V2927201
Product quantity
33 units
Voluntary mandated
Voluntary: Firm initiated
City
Versailles
State
OH
Country
United States
Event id
99641
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