FDA Device recall Z-3219-2026
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal),…
- FDA Device
- Class II
- ongoing
- Published 2026-09-30
On 2026-09-30 the FDA classified a Class II recall of Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal),… by Midmark, citing A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3219-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-21 |
| Published | 2026-09-30 |
| Last updated | 2026-10-06 05:30 UTC |
| Company | Midmark |
| Distribution | US |
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
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Identifiers
| code_info | Model No: 1-200-0350; UDI-DI: 00841709105821; Kit No: 4-000-0722; UDI-DI: 00841709105906; Kit Serial Number: V2866143…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-06 05:30 UTC. Current status: ongoing.
Other recalls by Midmark
- Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal),…
FDA Device · Class II · 2026-09-30 · Midmark - Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal),…
FDA Device · Class II · 2026-09-30 · Midmark - Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal),…
FDA Device · Class II · 2026-09-30 · Midmark - Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Software Version: Midmark IQecg Plugin versions starting with v10 a…
FDA Device · Class II · 2026-09-02 · Midmark - Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version: Midmark IQecg Plugin versions starting with v10 and pr…
FDA Device · Class II · 2026-09-02 · Midmark
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3219-2026%22
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