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Norav NR Series
NORAV MEDICAL LTD. · Model NR1207-3 Kit · UDI-DI 07290110253141
MWJ
Prescription
10
510(k) clearances
63
Adverse events (1 deaths)
5
Recalls
50
Facilities
Description
Kit includes: Norav Wireless 3In1 Acquisition Device NR1 (UDI: 7290110253134) for Resting-ECG combined with Respiration and Body-Movement - IEC type labelling. Input cable with 10 Patient leads IEC type and Banana connectors. Input cable with 5 Patient leads IEC type and Snap connectors.
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.