Recall Z-3178-2018
Permobil, Ab · initiated August 15, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Permobil powered wheelchairs, Model Numbers: (a) M300 PS, (b) C300 PS, (c) C350 PS, (d) C500 PS, (e) C400 PS Product Usage: The devices identified are intended to provide outdoor and indoor mobility to persons limited to a seated position that can operate a powered wheelchair.
Codes / lots: (a) M300 PS, Serial numbers: 2572023019 2572000069 2572000403 2572000293 2572000358 2572000298 2572000359 2572000089 2579000025 2572018895 2572018959 2572000487 2572000491 2572000488 2572000492 2572000489 2579000027 2572000490 2572000493 2572000736 2572000367 2572000766 2572000816 2572000905 2572000924 2572000765 2572000299 2572006070 2572017706 2572024924 2572000735 2572024257 2572003615 2572001137 2572001149 2572001168 2572001169 2572001289 2572001170 2572001324 2572015685 2572015835 2572000402 2572001470 2572001546 2572001649 2572001650 2572001468 2572001471 2572001739 2572001798 2572001757 2572001851 2572001758 2572001379 2572001829 2572001859 2572001756 2572001860 2572002162 2572002521 2572002696 2572002941 2572002960 2572002085 2572001738 2572002163 2572002275 2572002054 2572002277 2572002449 2572002695 2572002697 2572002940 2572003044 2572003043 2572003045 2572003027 2572003231 2572003367 2572003402 2572003403 2572003550 2572003515 2572003565 2572003618 2572003804 2572003863 2572004017 2572024869 2572024934 2572003867 2572004018 2572004053 2572024343 2572024870 2572024318 2572024300 2572004211 2572004325 2572004369 2572004372 2572004312 2572004371 2572024234 2572023921…
Reason for recall
This correction decision has been made because of a potential failure of one or both backrest bars providing back support. If one or both back support telescoping bars fail the user could fall back leading to a potential injury.
FDA-determined cause: Device Design
Action taken
The firm initiated the recall on 08/15/2018 by letter to the direct accounts (dealer/distributors). The letter instructed the consignee to contact the end users and perform the correction.
Details
- Recall number
- Z-3178-2018
- Initiated
- August 15, 2018
- Terminated
- May 3, 2021
- Product code
- ITI – Wheelchair, Powered
- Quantity
- 3134 units
- Distribution
- Worldwide Distribution - US Nationwide
- Recalling firm
- Permobil, Ab, Timra