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InBody Co., Ltd. · Model BPBIO220 · UDI-DI 08809209590815
1
510(k) clearances
3,169
Adverse events (16 deaths)
36
Recalls
429
Facilities
Description
The subject device is a manual blood pressure (BP) monitor, and requires the user to listen for Korotkoff sounds to determine systolic and diastolic pressure. Further, patients whose Korotkoff sounds are not clear or absent, such as children younger than 3 years of age, will not be suitable for the subject device. Pulse rate is also measured.
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.