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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2023-02-20Z-1417-2023Class IIOpen, ClassifiedThere are technical issues related to signal generation and processing, which can lead to inaccurate presentations.Distribution: Worldwide - US Nationwide distribution.549 units (75 US, 474 OUS)code info di
Regulatory clearances
  • 510(k)K132147Substantially equivalent (SESE) · 2013-12-16clearance family

Predicate lineage

Cited as predicate by: K132142, K160455, K181966

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2025-01-17OAIOfficial action indicatedPhilips Medical Systems Nederland B.V.0
2023-01-26OAIOfficial action indicatedPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.3
2010-09-21NAINo action indicatedPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.0
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