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SEER 1000 PC App

getemed Medizin- und Informationstechnik AG · Model V1.0SP03 · UDI-DI 04250903201196

MWJ Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

The SEER 1000 PC App is a software product which is an accessory to the SEER 1000 recorder. The SEER 1000 PC App assists in the hook-up procedure (e.g. displaying of ECG data and setting of patient demographic data).

Recalls

Date	Firm	Reason
2024-11-25	Spacelabs 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
2024-11-25	Spacelabs 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
2020-01-22	Braemar Manufacturing, LLC	An 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
2020-01-22	Braemar Manufacturing, LLC	An 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
2020-01-13	Philips North America, LLC	if 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.