Device product
DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 1654807 - DOLOMITE GLOSS 680 ROLLATOR 1655081 - DOLOMITE GLOSS 600 ROLLATOR 1655082 - DOLOMITE GLOSS 520 ROLLATOR 1655083 - DOLOMITE GLOSS 450 ROLLATOR
Z-2445-2023
Product summary
- Event
- Event 92645
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 586 devices
- Official record key
device-enforcement:Z-2445-2023
Official wording
Reason: Premature failure of the seat during use, the plastic eyelets of the folding mechanism of the device's seat can break, and in a worst-case crossbar also breaks and the Rollator can collapse causing injury to user
Code information: Serial number in the range: 20BHL0002 to 21IHL1910
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Premature failure of the seat during use, the plastic eyelets of the folding mechanism of the device's seat can break, and in a worst-case crossbar also breaks and the Rollator can collapse causing injury to user