Recall Z-1116-2025— Max Mobility LLC
Class I · Ongoing
Class I FDA medical device recall by Max Mobility LLC, initiated 2024-12-20. It names one FDA 510(k) clearance: K151199. Product: Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.. Reason: Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries..
- Recalling firm
- Max Mobility LLC
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-12-20
- Firm location
- Lebanon, TN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
Reason for recall
Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries.
Data sourced from openFDA. This site is unofficial and independent of the FDA.