Midmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings
Midmark Corporation is recalling 33 IQvitals Zone units 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 High severity criteria for potential harm without confirmed illness or injury.
Plain-English summary
Midmark Corporation is recalling 33 units of 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 1-200-0360 with Kit Number 4-000-0724.
The recall was initiated because a performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. The devices were distributed nationwide in the United States.
Healthcare facilities and consumers should check their inventory for the specific serial numbers listed in the recall notice. If a device is affected, it should be removed from service and returned to Midmark Corporation for evaluation or replacement.
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: 1-200-0360 with Kit Number: 4-000-0724
- Manufacturer
- Midmark Corporation
- Hazard
- Affected units
- 33
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 (4)
- Model No: 1-200-0360
- UDI-DI: 00841709105838
- Kit No: 4-000-0724
- UDI-DI: 00841709105913
Distribution
Distributed nationwide across the United States.
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