Home › MIDMARK CORPORATION › Midmark IQvitals Device Kit w/touchscreen - Blood Pressure, Temperature and SpO2
Midmark IQvitals Device Kit w/touchscreen - Blood Pressure, Temperature and SpO2
MIDMARK CORPORATION · Model 4-000-0510 · UDI-DI 00841709100819
DXN
Prescription
10
510(k) clearances
7,287
Adverse events (16 deaths)
36
Recalls
428
Facilities
Description
Midmark IQvitals is an affordable, Windows based device that provides automated blood pressure, temperature, SpO2 and pulse rate readings with a touch of the screen. Kit includes: IQvitals Device w/Blood Pressure, Temperature and SpO2, AC Power Supply, Reusable Blood Pressure Cuff - Adult, Reusable Blood Pressure Cuff - Large Adult, Blood Pressure Hose - 6.5', Reusable SpO2 Adult Finger Sensor, SpO2 Extender Cable - 4', Oral/Axillary Temperature Probe, Temperature Probe Covers (box of 20), Serial Cable - 10', and USB Cable - 10'.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-02-24 | PYRAMES INC | Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibratory noise, may not adequately detect changes in blood pressure per specification. C |
| 2024-08-30 | MEDLINE INDUSTRIES, LP - Northfield | It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as |
| 2024-08-30 | MEDLINE INDUSTRIES, LP - Northfield | It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as |
| 2024-08-30 | MEDLINE INDUSTRIES, LP - Northfield | It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as |
| 2024-03-26 | Baxter Healthcare Corporation | Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical s |
| 2024-03-26 | Baxter Healthcare Corporation | Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical s |
| 2024-03-26 | Baxter Healthcare Corporation | Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical s |
| 2024-02-26 | MEDLINE INDUSTRIES, LP - Northfield | The firm provided a set of specifications for the device, but some units of the device were manufactured non-compliant with the specifications. However, the firms Receiving Dept. a |
| 2021-05-17 | Mediana Co., Ltd. | In some cases the equipment fails to power up and/or key or button unresponsive or not working. |
| 2021-04-22 | Welch Allyn Inc | Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.