Scooter
- Recall Initiated
- April 1, 2021
- Recall Number
- Z-1505-2021
- Quantity
- 189 units
- Firm Location
- Fort Myers, FL
Reason for Recall
Seat baseplate pin has broken in the field.
Distribution
Distributed nationwide to AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IO, KS, KY, LA, MN, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, SC, TN, TX, UT, VT, VA, WA, WV, WI and internationally to Canada
Lot / Code Info
Pioneer 3 Scooter - Model Number: S131; Part No: S13152ARMU; Serial Numbers: MU200900928, MU200600612, MU200600610, MU200600887, MU200600621, MU200600620, MU200600619, MU200600618, MU200600608, MU200600616, MU200600609, MU200600607, MU200600615, MU200600613, MU200900930, MU200600892, MU200600874, MU200600889, MU200600877, MU200600617, MU200600888, MU200600876, MU200600883, MU200600879, MU200600885, MU200900923, MU200600886, MU200600893, MU200600890, MU200600611, MU200600875 Pioneer 3 Scooter - Model Number: S131; Part No: S13152SBMU; Serial Numbers: MU200900944, MU200900942 Pioneer 4 Scooter - Model Number: S141; Part No: S14151ARMU; Serial Numbers: MU200900956, MU200900953 Pioneer 4 Scooter - Model Number: S141; Part No: S14152ARMU; Serial Numbers: MU200800943, MU200600346, MU200600353, MU200600357, MU200800940, MU200900961, MU200801127, MU200801132, MU200800947, MU200600360, MU200800938, MU200801131, MU200600358, MU200600359, MU200600344, MU200801134, MU200600354, MU200600356, MU200600351, MU200600345, MU200600355, MU200600348, MU200801122, MU200801128, MU200900971, MU200600347, MU200600361, MU200600352, MU200600349, MU200600350, MU200800931, MU200800951, MU200800949, MU200801121, MU200800941, MU200800939, MU200800942, MU200801133, MU200801125, MU200900970, MU200801123 Pioneer 4 Scooter - Model Number: S141; Part No: S14152SBMU; Serial Numbers: MU200800952, MU200501029, MU200500382, MU200501033, MU200500381, MU200501039, MU200500363, MU200500359, MU200801161, MU200500372, MU200801157, MU200501031, MU200500364, MU200501044, MU200501042, MU200800962, MU200500378, MU200601118, MU200601123, MU200601112, MU200601110, MU200601111, MU200800957, MU200801152, MU200800976, MU200601114, MU200601121, MU200601126, MU200800975, MU200801168, MU200901022, MU200501032, MU200501046, MU200901029, MU200901020, MU200500376, MU200501028, MU200501036, MU200501041, MU200501037, MU200501040, MU200601125, MU200601120, MU200501047, MU200501038, MU200501043, MU200501034, MU200501035, MU200501030, MU200601116, MU200601117, MU200601115, MU200901004, MU200901023, MU200901007, MU200901014, MU200901008, MU200901016, MU200901000, MU200601113, MU200500365, MU200500373, MU200500371, MU200500361, MU200500374, MU200500367, MU200800973, MU200500360 Pioneer 1 Scooter - Model Number: S235; Part No: S2354-ARMUB; Serial Numbers: MU200600053, MU200600052, MU200600051, MU200600054 Pioneer 1 Scooter - Model Number: S235; Part No: S2354-SBMUB; Serial Numbers: MU200600056, MU200600058, MU200600059 Pioneer 2 Scooter - Model Number: S245; Part No: S2454-ARMUB; Serial Numbers: MU200400958, MU200400969, MU200601135, MU200400960, MU200400967, MU200400968, MU200400965, MU200400964, MU200400966, MU200400962, MU200400963 Pioneer 2 Scooter - Model Number: S245; Part No: S2454-SBMUB; Serial Numbers: MU200400975, MU200400988, MU200400979 Pioneer 9 Scooter - Model Number: S331; Part No: S331-1ARMU; Serial Numbers: MU200801178, MU200700070, MU200700075, MU200700076, MU200700069, MU200801188 Pioneer 10 Scooter - Model Number: S341; Part No: S341-1ARMU; Serial Numbers: MU200800993, MU200800992, MU200800991, MU200800994, MU200800979, MU200800977, MU200800983, MU200800989, MU200800995, MU200800990 Silverado Extreme Scooter - Model Number: S940; Part No: S940A-SDMU; Serial Numbers: MU200800528, MU200700079, MU200800531, MU200800526, MU200800535, MU200700085, MU200700081 Silverado Scooter - Model Number: S941; Part No: S941A1SVMU; Serial Numbers: MU200800538
Root Cause
Process change control
Action Taken
A Recall notification letter titled, "MEDICAL DEVICE FIELD CORRECTION" was sent to consignees on 04/07/2021 via email and by certified mail on 04/16/2021. The firm stated they made phone call notifications on 04/01/2021. The letter instructs the consignee to Contact impacted customer using a personalized customer letter (template provided). The notification can be sent by mail, email or phone. (IF by phone, please keep a log of call. Date/Time/Result); replace the old seat plate with new one provided using the SOP provided. The field correction should take approximately 15 minutes to complete.; complete and return the Service and Repair Report (sent with new part), inspect the installation and note it on the appropriate Scooter or Power Chair Inspection Record provided; use the RA shipping label (sent with new part) and return old seat plate to Merits Health Products along with the Service and Repair Report (one filled out for each unit); and when all of the units in the possession of the consignee are finished, please return the completed Inspection Report/s to Merits by mail or email.