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SELECT TL3

Pressalit A/S · Model R9043 · UDI-DI 05708590372792

IKX
10
510(k) clearances
2,573
Adverse events (25 deaths)
20
Recalls
284
Facilities

Description

SELECT TL3 toilet bracket, for wall outlet, 120V, white single molded cover. Manually height adjustable with crank handle

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.