Midmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings
Midmark Corporation is recalling IQvitals Zone devices because a performance issue may cause inaccurate blood pressure readings when using the Linear Deflation Method.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Midmark Corporation is recalling the IQvitals Zone, a medical device that automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature, and oxygen saturation for adult and pediatric patients. The recall involves Model Number 1-200-0320 with Kit Number 4-000-0622.
The recall is due to a performance issue that may result in inaccurate blood pressure readings when the Linear Deflation Method is used. The source text does not specify the number of units affected or report any specific injuries or illnesses.
The devices were distributed nationwide in the United States. Consumers and healthcare providers should contact Midmark Corporation for instructions on how to address the performance issue.
The recalled product
- 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
- Manufacturer
- Midmark Corporation
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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
Distributed nationwide across the United States.
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