Midmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings
Midmark Corporation is recalling 20 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 medical device that may provide inaccurate vital signs, which poses a risk of harm to patients, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Midmark Corporation is recalling 20 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 is due to a performance issue that may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
The affected devices are Model Number 1-200-0350 with Kit Number 4-000-0722. The recall covers units distributed nationwide in the United States. Specific serial numbers for the affected kits and zones are listed in the official recall documentation.
Healthcare facilities and consumers should stop using the affected devices and contact Midmark Corporation for instructions on how to proceed with the recall.
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: 1-200-0350 with Kit Number: 4-000-0722
- Manufacturer
- Midmark Corporation
- Hazard
- Affected units
- 20
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: 1-200-0350
- UDI-DI: 00841709105821
- Kit No: 4-000-0722
- UDI-DI: 00841709105906
Distribution
Distributed nationwide across the United States.
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