| Class 2 Device Recall SmartDrive MX2 component PushTracker E3 | |
Date Initiated by Firm | May 10, 2023 |
Date Posted | June 26, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2005-2023 |
Recall Event ID |
92250 |
510(K)Number | K151199 |
Product Classification |
Wheelchair, powered - Product Code ITI
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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 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
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For Additional Information Contact | Audra 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 |
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 | 6,196 units |
Distribution | Worldwide distribution. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = ITI
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