Recall Z-0142-2015 ยท ITJ Walker, Mechanical
Briggs Medical Service Company d.b.a. Mabis
DMI Duro-Med Industries Rollator Transport Chair; Wheel Size: 7 1/4"; Overall Width: 23 1/2"; Seat Height: 21 1/4"; Seat Size: 14" x 12 3/4"; Handle Height: 31" - 36"; Width Between Handles: 18"; Weight: 19 Lbs; Walking assistance device.
| Date | Oct 28, 2014 (initiated Jun 5, 2014) |
| Status | Terminated |
| Reason | There have been 5 customer reports of a 501-1018 series DMI Rollator Transport Chair collapsing during use. |
| Root cause | Device Design |
| Action | The firm, Briggs Healthcare, sent "URGENT PRODUCT RECALL" letters dated July 28, 2014 to all distributors, retailers and consumers. The letters included instructions for distributors and dealers to: 1) examine their inventory; 2) quarantine any affected products; 3) cease distribution of the affected products; and, 4) complete and return the attached Customer Recall Acknowledgement Form. Distributors and dealers who further distributed the products were also instructed to notify their customers of this recall by forwarding a copy of the enclosed consumer notification letter and its associat |
| Quantity | 1,869 units |
| Distribution | Worldwide Distribution: US (nationwide) including states of:US: Nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY) + District of Columbia + Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.