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Norav 1200 Series
Norav Medical GmbH · Model ECGUSB1DEX Kit · UDI-DI 04260498564255
MWI
Prescription
10
510(k) clearances
1,983
Adverse events (45 deaths)
81
Recalls
171
Facilities
Description
Kit includes: Single Channel ECG Acquisition Module (DI no.: 04260498564262) for integration in other Medical Devices. ECG Input Cable, 3 leads, IEC color coding Special edition for GE Health Care.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-20 | GE Medical Systems Information Technologies Inc | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and |
| 2026-07-20 | GE Medical Systems Information Technologies Inc | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and |
| 2026-07-20 | GE Medical Systems Information Technologies Inc | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and |
| 2026-07-20 | GE Medical Systems Information Technologies Inc | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and |
| 2026-07-10 | GE Medical Systems Information Technologies Inc | Portrait Core Services Software version V1.2.0 Security Vulnerability |
| 2026-01-30 | Covidien LLC | Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring s |
| 2025-10-24 | Edan Diagnostics | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. |
| 2025-05-22 | CHANGE HEALTHCARE CANADA COMPANY | Due to complaints, software update may cause software to unexpectedly shutdown. |
| 2025-05-22 | CHANGE HEALTHCARE CANADA COMPANY | Due to complaints, software update may cause software to unexpectedly shutdown. |
| 2025-03-24 | Baxter Healthcare Corporation | There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batter |
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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.