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WowGoHealth Automatic Arm Bluetooth Blood Pressure Monitor

GOLDEN SMART HOME TECHNOLOGY CORP. · Model GSH862 · UDI-DI 04719878120036

DXN
1
510(k) clearances
3,560
Adverse events (16 deaths)
36
Recalls
430
Facilities

Description

Automatic Arm Bluetooth Blood Pressure Monitor GSH862, intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The devices’ features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected.The devices’ feature include Bluetooth function to transmit data to an external Bluetooth device with wireless communication. The devices are intended to use of Over-The-Counter.

Recalls

DateFirmReason
2025-02-24PYRAMES INCSingle-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
2024-08-30MEDLINE INDUSTRIES, LP - NorthfieldIt 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
2024-08-30MEDLINE INDUSTRIES, LP - NorthfieldIt 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
2024-08-30MEDLINE INDUSTRIES, LP - NorthfieldIt 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
2024-03-26Baxter Healthcare CorporationBaxter 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
2024-03-26Baxter Healthcare CorporationBaxter 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
2024-03-26Baxter Healthcare CorporationBaxter 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
2024-02-26MEDLINE INDUSTRIES, LP - NorthfieldThe 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
2021-05-17Mediana Co., Ltd.In some cases the equipment fails to power up and/or key or button unresponsive or not working.
2021-04-22Welch Allyn IncPotential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock

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Data 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.