Device recall
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 number
- Z-3217-2026
- Event id
- 99641
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Midmark Corporation
- Report date
- Sep 30, 2026
- Posted
- Sep 18, 2026
- Initiated
- Aug 21, 2026
- Center classification date
- Sep 18, 2026
- Product code
- MWI
- Device type
- Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Reason
- A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
- Root cause
- Process change control
- Quantity
- 1 units
- Code info
- Model No: 1-200-0320; UDI-DI: 00841709105791; Kit No: 4-000-0622; UDI-DI: 00841709105876; Kit Serial Number: V2900924; Zone Serial Number: V2899738
- Distribution
- US Nationwide distribution.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K161909
- Location
- Versailles, OH, United States