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U.S. Department of Health and Human Services

Class 2 Device Recall SmartDrive MX2 component PushTracker E2

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 Class 2 Device Recall SmartDrive MX2 component PushTracker E2see related information
Date Initiated by FirmMay 10, 2023
Date PostedJune 26, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2004-2023
Recall Event ID 92250
510(K)NumberK151199 
Product Classification Wheelchair, powered - Product Code ITI
ProductPushTracker 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 All units with software versions 1.0.00 to 1.0.04
Recalling Firm/
Manufacturer		 Permobil
300 Duke Dr
Lebanon TN 37090-8115
For Additional Information ContactAudra Watt
800-736-0925
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionPermobil 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 Commerce18,905 units
DistributionWorldwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = ITI
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