FDA recall Z-1100-2021

Arjohuntleigh Magog, Inc. · Class II · device

Product

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.

Reason for recall

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

Distribution

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 and Poland.

Key facts

Status
Terminated
Initiation date
2020-10-06
Report date
2021-02-17
Termination date
2025-07-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Magog, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1100-2021