Midmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings
Midmark Corporation is recalling 153 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 sign readings, which poses a risk of harm to patients if relied upon for clinical decisions, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Midmark Corporation is recalling 153 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 identified by Model Number 1-200-03300 and Kit Number 4-000-0624. Specific serial numbers for the kits and zones are listed in the official recall documentation. The devices were distributed nationwide in the United States.
Healthcare providers and consumers should stop using the affected IQvitals Zone units for blood pressure measurement via the Linear Deflation Method. Users should contact Midmark Corporation for instructions on how to proceed with the recall and potential replacement or repair.
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: 1-200-03300 with Kit Number: 4-000-0624
- Manufacturer
- Midmark Corporation
- Hazard
- Affected units
- 153
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: 1-200-0330
- UDI-DI: 00841709105807
- Kit No: 4-000-0624
- UDI-DI: 00841709105883
Distribution
Distributed nationwide across the United States.
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