FDAClass IIJuly 5, 2023

PushTracker E2 component utilized with the SmartDrive recall

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…

Why was PushTracker E2 component utilized with the SmartDrive 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All units with software versions 1.0.00 to 1.0.04

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…
Recalling firm
Permobil
Quantity
18,905 units
Distribution
Worldwide distribution.
Recall date
July 5, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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