Medical device recalls Moderate risk

Arjohuntleigh Magog, Inc. recalls Arjo Flat Dynamic Positioning System (DPS) - Product Usage: used in conjunction with passive clip slings is designed fo…

Recall date
October 6, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1100-2021
FDA classification
Class II
Brand / firm
Arjohuntleigh Magog, Inc.
Sold / distributed
Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, GA, IA, ID, IL, IN, KS, KY, LA, MI, MN, MO, MS, MT, NC, NE, NH, NY, OH, OK, SC, SD, TN, TX, UT, VA, WI and the countries of Australia, Belgium, Canada, Czech Republic, France, Italy an…

Why it was recalled

Risk of Sling Clip breakage while in use with obsolete Flat Dynamic Positioning System (DPS)

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Arjo Flat Dynamic Positioning System (DPS) - Product Usage: used in conjunction with passive clip slings is designed for resident transfer in a homecare setting, at nursing homes and other assisted living centers. Please note that the DPS can be utilized only if affixed to ceiling lift or passive floor lift.

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