FDA-Device2026-09-30Class IIPROCESSING DEFECT
Midmark IQvitals Zone vital signs monitor recalled for inaccurate blood pressure readings
What this means
Midmark Corporation's IQvitals Zone vital signs monitor may produce inaccurate blood pressure readings when using the Linear Deflation Method. The issue affects a limited number of units with specific serial numbers distributed nationwide. No injuries have been reported.
- Check if your device serial number matches the affected list provided by Midmark
- Contact Midmark Corporation for instructions on how to address this issue
- Do not rely solely on this device for blood pressure readings until the issue is resolved
The agency's original wording
Hazard
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Intended for
All ages (0 months and older)
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
20 units
Manufactured in
60 Vista Dr, Versailles, OH, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3219-2026More Midmark recalls
- FDA-Device2026-09-30Midmark IQvitals Zone vital signs monitor recalled for inaccurate blood pressure readings
- FDA-Device2026-09-30Midmark IQvitals Zone blood pressure monitor recalled for inaccurate readings
- FDA-Device2026-09-30Midmark IQvitals Zone vital signs monitor recalled for inaccurate blood pressure readings
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