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Norav 1200 Series PC-ECG

NORAV MEDICAL LTD. · Model 1200HRT Kit · UDI-DI 07290110255282

MWI Prescription

510(k) clearances

1,983

Adverse events (45 deaths)

Recalls

171

Facilities

Description

Kit includes: PC-ECG 1200HR (UDI: 07290110255275) for High Resolution Resting-ECG and Stress-Test ECG recordings with ECG Trigger Output and IEC type labelling. Input cable with 10 Patient leads IEC type and Snap connectors. Special edition LO Kit for COSMED

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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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.