Z-2004-2023Class II

PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K...

Name: Z-2004-2023 PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K...
Creator: Permobil
Published: 2023-05-10
License: https://open.fda.gov/license/

Permobil, AB / initiated 2023-05-10 / Open, Classified / root cause: software

FDA source

Permobil began a recall of PushTracker E2 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... on 2023-05-10. FDA classified it as Class II and gives the reason as "When 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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2004-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-10
Posted: 2023-06-26
Recalling firm: Permobil, AB
Product: PushTracker E2 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
Product code: ITI Wheelchair, Powered
Reason for recall: When 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.
Root cause tag: software
FDA root cause: Software design
Action: Permobil began notifying customers via in-person and through letters on 05/10/2023. Customers were instructed to examine their device and update their software to SmartDrive MX2+ Version 1.1.00, to acknowledge the update was conducted and the notification letter was understood through the field action portal, notify customers if the affected devices were further distributed. They were also instructed to discontinue using the affected device while waiting for the correction.
Quantity in commerce: 18,905 units
Distribution: Worldwide distribution.
Product codes and lots: All units with software versions 1.0.00 to 1.0.04

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2004-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2004-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-26
Z-2005-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-26

Product code ITI

K151199Class IISmartDrive Wheelchair Power AssistMax Mobility, LLC / cleared 2015-07-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)