Agency classClass IIOur severity:High FDA (Devices)·Z-2005-2023·Announced 2023-07-05

PushTracker E3 software failure may prevent stopping SmartDrive motor

A software defect in the PushTracker E3 watch can cause the SmartDrive motor to run uncontrollably, and users may not be able to stop the device using tap controls. Approximately 6,196 units worldwide are affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a FDA Class II recall involving loss of motor control on a mobility device. No illnesses or injuries have been reported. The hazard is a software defect that prevents device shutdown, presenting a risk but without documented harm incidents.

Plain-English summary

Permobil is recalling the PushTracker E3 component, a wearable watch used with the SmartDrive MX2+ Power Assist Device to control wheelchair motors. Approximately 6,196 units worldwide are affected, specifically those with software versions 1.0.00 through 1.0.04.

A software defect can cause the watch application to fail unexpectedly when multiple processes run simultaneously on its central processing unit. When this occurs, the motor on the power assist device continues to run. Users may not be able to stop the device using tap gesture controls.

This defect creates a risk that wheelchair users may lose control of their mobility device and be unable to stop it, presenting a potential safety hazard.

The recalled product

Product: PushTracker 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…
Manufacturer: Permobil
Category: Medical Device — Assistive mobility technology
Hazard: software-failure
loss-of-control
unintended-operation
Affected units: 6,196

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All units with software versions 1.0.00 to 1.0.04

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Permobil under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Permobil

See all →

High
PushTracker E2 watch app may crash, disabling wheelchair motor controls
FDA (Devices) · 2023-07-05

Same hazard · software failure