ClearanceBrief
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.

DateOct 28, 2014 (initiated Jun 5, 2014)
StatusTerminated
ReasonThere have been 5 customer reports of a 501-1018 series DMI Rollator Transport Chair collapsing during use.
Root causeDevice Design
ActionThe 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
Quantity1,869 units
DistributionWorldwide 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 recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.