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Q Patch Mobile Application

MEDICALGORITHMICS S A · Model 1.0 · UDI-DI 05903021560155

MWJ Prescription
1
510(k) clearances
63
Adverse events (1 deaths)
5
Recalls
50
Facilities

Description

Q Patch Mobile Application (Mobile application) – The Q Patch Mobile Application is intended to be used for interacting with the Q Patch recorder for transmission patient data to set up ECG recording session and displaying the Q Patch’s status. The application is obligatory for healthcare professionals and optional for patients

Recalls

DateFirmReason
2024-11-25Spacelabs Healthcare, Ltd.Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match
2024-11-25Spacelabs Healthcare, Ltd.Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match
2020-01-22Braemar Manufacturing, LLCAn issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This issue can prevent the recorder from operating normally. Braemar confirmed that be
2020-01-22Braemar Manufacturing, LLCAn issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This issue can prevent the recorder from operating normally. Braemar confirmed that be
2020-01-13Philips North America, LLCif an AAA battery is inserted in the recorder and a user attempts to start it, or if the recorder is inserted in the docking station, the recorder will display Error: 602 and fai

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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.