RegWardenFDA facility compliance records
Recall

Class II — Permobil

Recalling firmPermobil (KunShan) Co., Ltd
Registered facilityPERMOBIL (KUNSHAN) CO., LTD (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonWhen multiple processes are running on the watch's Central Processing Unit (CPU), the application may fail unexpectedly. If this happens, the motor on the power assist device continues to run and the user may not be able to stop the device using tap gestures.
ProductPushTracker E3 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32PK, MX2-33D, MX2-33P, MX2-33PK, MX2-33S, MX2-150, MX2-167, MX2-32D); a wearable watch that communicates with a SmartDrive Power Assist Device via the SmartDrive MX2+ Application
Quantity6,196 units
DistributionWorldwide distribution.
Initiated2023-05-10
Classified2023-06-26
Recall numberZ-2005-2023
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Permobil (Z-2005-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92250/

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