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Norav 1200 Series PC-ECG

Norav Medical GmbH · Model 1200W Kit · UDI-DI 04260498566952

MWI Prescription

510(k) clearances

2,174

Adverse events (46 deaths)

Recalls

174

Facilities

Description

Kit includes: PC-ECG 1200W (UDI: 04260498565054) wireless Stress-Test Kit (Rev.02), GE-Service; PC-ECG 1200WR (UDI: 04260498566907) Receiver Unit Input cable with ten leads AHA type and Clip connectors. Special edition for GE Health Care.

Recalls

Date	Firm	Reason
2026-08-21	Midmark Corporation	A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
2026-08-21	Midmark Corporation	A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
2026-08-21	Midmark Corporation	A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
2026-08-21	Midmark Corporation	A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
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	A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or acc
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

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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.