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SEER 1000
getemed Medizin- und Informationstechnik AG · Model 7 day - Korean · UDI-DI 04250903200748
MWJ
Prescription
10
510(k) clearances
63
Adverse events (1 deaths)
5
Recalls
50
Facilities
Description
The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
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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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.