Official recall notice
FDA DeviceClass IINotable
Midmark IQvitals Zone automatically Recall (Sep 2026)
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
- Recall date
- 2026-09-30
- Brand
- Midmark Corporation
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Product description
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Affected products
Model No: 1-200-0320; UDI-DI: 00841709105791; Kit No: 4-000-0622; UDI-DI: 00841709105876; Kit Serial Number: V2900924; Zone Serial Number: V2899738