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HeadSet 3T

Nordicneurolab AS · Model 1.0 · UDI-DI 07090042053068

LNH
1
510(k) clearances
4,751
Adverse events (37 deaths)
711
Recalls
145
Facilities

Description

nordicAudio is an audio system for use in MR, consisting of a HeadSet with BatteryBox and an AccessPoint in the MR Room. An AudioHub and a BatteryCharger is placed in the operator room.

Recalls

DateFirmReason
2026-08-21Philips North America LlcA software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the
2026-08-21Philips North America LlcA software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the
2026-08-21Philips North America LlcA software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the
2026-08-21Philips North America LlcA software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the
2026-08-21Philips North America LlcA software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the
2026-08-21Philips North America LlcA software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the
2026-08-21Philips North America LlcA software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the
2026-08-21Philips North America LlcA software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the
2026-08-21Philips North America LlcA software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the
2026-08-21Philips North America LlcA software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the

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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.