Atlas FDA

Victory 9 with Power Seat (SC609PS) Motorized wheelchair with elevating seat.

FDA device recall Z-1941-2012 · posted 2012-07-03 · Terminated

Recall details

Recalling firm
Pride Mobility Products Corp
Reason for recall
The main harness connector was manufactured without the required back shield sealing protection. As a result, there is the potential for water to seep through the nonconforming harness.
Action taken
Three (3) pieces of information was distributed in the notification. They are: (1) Letter of Correction to the Provider (2) Letter of Correction for the Consumer (provider to issue to consumer) (3) Product Insert for Victory 9 Controller Interface Harness Replacement. The letter of Correction for Victory 9 with Power Sear (SC609PS), dated November 2010, identified the affected product and the reason for the correction. Customers were to record the serial number(s) and contact their provider's office to make an appointment to have the harness replaced.
Root cause
Nonconforming Material/Component
Status
Terminated
Product code
INI
Quantity affected
186
Distribution
Worldwide Distribution
Date initiated
2010-11-26
Date posted
2012-07-03
Date terminated
2013-03-22
Location
Exeter, PA

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Related 510(k) clearances

RecordFirmDate
VICTORY THREE WHEEL SCOOTER, MODEL: SC610 (K072165)Pride Mobility Products Corp.2007-08-17