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EasyShift

Seneca Devices, Inc. · Model EAS-36-Z · UDI-DI 00860004936848

FNKIKZ
1
510(k) clearances
52
Adverse events (11 deaths)
4
Recalls
17
Facilities

Description

EasyShift Repositioning System V3 for 36-inch wide mattress

Recalls

DateFirmReason
2014-04-18Med-Mizer, Inc.All configurations of the SS Retractabed, Clinical Contour, made prior to June 7 2008 may have had insufficient welding on the foot cross tube. This tube is responsible for hold
2014-04-18Med-Mizer, Inc.All configurations of the SS Retractabed, Clinical Contour, made prior to June 7, 2008 may have had insufficient welding on the foot cross tube. This tube is responsible for hol
2011-05-02Linet Americas IncLinet has been made aware that there has been breakage of the Mobi-lift handle on a few beds which may cause failure during patient assist use.
2011-02-24Arjo, Inc. dba ArjoHuntleighPart of the housing of the strap retracting mechanism built into the handle may break while the patient is using the handle and strap.

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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.