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Immedia

Etac Immedia A/S · Model SatinSheet 2Direction Corner wide · UDI-DI 05708012003105

IKX
10
510(k) clearances
2,515
Adverse events (25 deaths)
20
Recalls
281
Facilities

Recalls

DateFirmReason
2024-11-05NOA Medical Industries IncRed button used to engage side rails can break or become stuck making it difficult to engage the side rail.
2020-09-15Medline Industries IncThe buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation.
2017-08-10Medline Industries IncThe locking mechanism on the belt may fail to secure/hold the strap when in locked position potentially allowing the belt strap to slip through the buckle.
2017-08-10Medline Industries IncThe locking mechanism on the belt may fail to secure/hold the strap when in locked position potentially allowing the belt strap to slip through the buckle.
2017-05-30EOS ImagingROTH MOBELI grab handles could detach and patient could fall if the EOS system operator does not follow instructions. Before each use, the operator must examine the vacuum safety i
2015-03-26Handicare USA, Inc.Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied.
2014-04-15Handicare USA, Inc.During the period of April 2009 May 2011, Handicare AB used a wing handle in which the screw and handle, after repeated tightening, may slide apart. This causes a small amount of
2012-03-20North Coast Medical IncDue to a consumer complaint, North Coast Medical determined that due to a design flaw, there was not enough plastic support material to retain bracket bolts when subjected to a for
2009-07-09Nutech Manufacturing CorpSafety chair used in shower/bath may not meet specifications for weight load.
2009-07-09Nutech Manufacturing CorpSafety chair used in shower/bath may not meet specifications for weight load.

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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.