Midmark IQvitals Zone, Wireless with Nellcor SPO2Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K161909); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Aug 21, 2026Class IIOpen, Classified

   A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.

   Z-3219-2026 · Root cause: Process change control · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161909. One submission often covers many models, so check the product and lot details in each record.

• Z-3217-2026 · Aug 21, 2026 · Open, Classified
  Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult an
• Z-3218-2026 · Aug 21, 2026 · Open, Classified
  Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult an
• Z-3220-2026 · Aug 21, 2026 · Open, Classified
  Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult an