Device product

Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager Rollator Cobalt Blue UPC: 815067078066; RLEU10PK Voyager Rollator Rose Gold UPC: 815067078073; RLEU10WT Voyager Rollator Ice Palace UPC: 815067078080

Z-0510-2022

January 10, 2022

Class II

Product summary

Firm: Compass Health Brands (Corporate Office)
Event: Event 89389
Status: Ongoing
Classification: Class II
Quantity: 3734 units
Official record key: device-enforcement:Z-0510-2022

Official wording

Reason: Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries, including bruising and lacerations requiring stitches.

Code information: Lot/Serial # RM2005000001-RM21004005000 (May 2020 through April 2021 manufacture dates)

Distribution pattern: Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries, including bruising and lacerations requiring stitches.