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: 1-200-0350 with Kit Number: 4-000-0722
- Recall number
- Z-3219-2026
- 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
- 20 units
- Code info
- 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
- Distribution
- US Nationwide distribution.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K161909
- Location
- Versailles, OH, United States