Z-1100-2021 Class II Terminated
FDA device recall Z-1100-2021 was initiated by Arjohuntleigh Magog, Inc. on October 6, 2020 and is designated Class II. Reason for recall: Risk of Sling Clip breakage while in use with obsolete Flat Dynamic Positioning System (DPS) The recall status is terminated (terminated July 23, 2025). Affected quantity: 3390 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 17, 2021
- Initiation Date
- October 6, 2020
- Termination Date
- July 23, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3390 units
Product Description
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 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.
Code Information
LBA1030-xx, LCA80563-xx, LCA81695-xx, KTX01440.xx, LBX05420-xx, LBX1033-xx, KTS0010