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AccessPoint
Nordicneurolab AS · Model 1.0 · UDI-DI 07090042053082
1
510(k) clearances
4,751
Adverse events (37 deaths)
711
Recalls
145
Facilities
Description
nordicAudio is an audio system for use in MR. The AccessPoint is placed in the MR-room. It is connected to the AudioHub in the operator room via a fiber connection and provides a connection point in the MR room for the fiber cable from the HeadSet.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-21 | Philips North America Llc | A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the |
| 2026-08-21 | Philips North America Llc | A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the |
| 2026-08-21 | Philips North America Llc | A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the |
| 2026-08-21 | Philips North America Llc | A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the |
| 2026-08-21 | Philips North America Llc | A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the |
| 2026-08-21 | Philips North America Llc | A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the |
| 2026-08-21 | Philips North America Llc | A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the |
| 2026-08-21 | Philips North America Llc | A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the |
| 2026-08-21 | Philips North America Llc | A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the |
| 2026-08-21 | Philips North America Llc | A 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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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.