openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 2
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries.
These labels are deterministic app interpretations, not FDA categories.
Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries.
Code information
All serial numbers manufactured between August 17,2023 through November 21, 2024
Distribution pattern
US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY OUS: Sweden, Canada, Australia, Japan, New Zealand, Colombia, Argentina, Hong Kong, Canada, Mexico, Bermuda, South Korea, Chile
device · product 2 of 2
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries.
These labels are deterministic app interpretations, not FDA categories.
Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries.
Code information
All serial numbers manufactured between August 17,2023 through November 21, 2024
Distribution pattern
US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY OUS: Sweden, Canada, Australia, Japan, New Zealand, Colombia, Argentina, Hong Kong, Canada, Mexico, Bermuda, South Korea, Chile
