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PushTracker E2 component utilized with the SmartDrive MX2+… recallZ-2004-2023 · Permobil · initiated May 10, 2023

Class II Open, Classified All recalls posted in June 2023

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Permobil or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Software design

What the company is doing

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.

Recall details

Recall number
Z-2004-2023
Recall class
Class II
Status
Open, Classified
Initiated by the company
May 10, 2023
Posted by the FDA
Jun 26, 2023
Recalling firm
Permobil
Quantity
18,905 units
Product code
ITI
FDA submissions
K151199
Distribution
Worldwide distribution.

Product description

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

Code information (models, lots, serial numbers)

All units with software versions 1.0.00 to 1.0.04

Other devices under the same FDA submission

2 devices cleared under K151199 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 92250).

Sources and updates

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