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Blood pressure monitor
AVITA CORPORATION · Model BPA-O300 · UDI-DI 04710953421161
10
510(k) clearances
3,560
Adverse events (16 deaths)
36
Recalls
429
Facilities
Description
The device is a arm type blood pressure monitor intended for automatically measures systolic and diastolic blood pressure and pulse rate by the oscillometric method. The measurement position is at the arm.The cuff circumference is limited to 220 mm - 420 mm (approx.:9 - 17 inches).The device is intended for home use. When the device detects irregular heart beats during measurement, an irregular heartbeat symbol will appear along with the measured readings
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.