PushTracker E3 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32P
Summary
The FDA issued a Class II for PushTracker E3 component utilized with the SmartDrive MX2+ Power Assist Device ( by Permobil. Reason: When multiple processes are running on the watch's Central Processing Unit (CPU), the application may fail unexpectedly. If this happens, the motor on.
Details
Source
Device Recall
External ID
Z-2005-2023
Action Date
2023-07-05
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: All units with software versions 1.0.00 to 1.0.04
Quantity Affected: 6,196 units
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.
Distribution
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-10
Company
Lebanon, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 367 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Permobil has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Permobil) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Permobil have FDA actions?
Permobil has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2005-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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