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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
2025-06-10Z-0262-2026Class IIOpen, ClassifiedSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.Distribution: US: CA, IL, and NJ8 unitscode info di
2024-01-22Z-1754-2024Class IIOpen, ClassifiedPotential interference with the anti-fall system.Distribution: Worldwide distribution - US Nationwide in the states of CA, IL, NJ, and areas yet to be identified by Philips Medical Systems DMC GmbH, Hamburg, Germany.636 devicescode info di
Regulatory clearances

    Predicate lineage

    K090322

    Cited as predicate by: K103597, K111725, K142492

    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
    2025-01-24OAIOfficial action indicatedSEDECAL SA4
    2013-06-28VAIVoluntary action indicatedSEDECAL SA2
    2010-01-15NAINo action indicatedSEDECAL SA0
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