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