Recall Z-1100-2021 ยท FSA Lift, Patient, Non-Ac-Powered
Arjohuntleigh Magog, Inc.
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.
| Date | Oct 6, 2020 |
| Status | Terminated |
| Reason | Risk of Sling Clip breakage while in use with obsolete Flat Dynamic Positioning System (DPS) |
| Root cause | Nonconforming Material/Component |
| Action | On 10/06/2020, the firm sent a letter to its consignees with the following instructions. Arjo has become aware that there is a likelihood that a sling clip may break (Image 2) when used with the models of spreader bars referenced above that are out of their lifespan (see note 1 below). The continued use of the obsoleted DPS can lead to complete clip breakage and subsequently to its detachment from the DPS attachment point. As a consequence, the resident may fall off and potentially sustain serious injuries as a consequence. Arjo is taking this matter very seriously and recommends replacement |
| Quantity | 3390 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.