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Recall Observatory FDA recall evidence

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.

Z-1100-2021

October 06, 2020

Class II

Product summary

Firm
Arjohuntleigh Magog, Inc.
Event
Event 86578
Status
Terminated
Classification
Class II
Quantity
3390 units
Official record key
device-enforcement:Z-1100-2021

Official wording

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

Code information: LBA1030-xx, LCA80563-xx, LCA81695-xx, KTX01440.xx, LBX05420-xx, LBX1033-xx, KTS0010

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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