Class 2 Device Recall Milford Smartbase

• Date Initiated by Firm: March 07, 2018
• Create Date: April 18, 2018
• Recall Status: Open, Classified
• Recall Number: Z-1420-2018
• Recall Event ID: 79627
• Product Classification: Lift, patient, non-ac-powered - Product Code FSA
• Product: Product: Milford Smartbase Model # 9934105 Pride SmartBase Pride product codes: LSMPLCG A & LSMPLCG B
• Code Information: All Lots
• Recalling Firm/ Manufacturer: Autochair; Wood St North; Meadow Lane Industrial Estate; Alfreton United Kingdom
• Manufacturer Reason for Recall: Recalling firm was informed that as a result of combination of a weak spring and incorrect alignment of the locking pin for latching the leg positions, product legs folded inwards while lifting a person off a bed and the individual was dropped.
• FDA Determined Cause: Component design/selection
• Action: Autochair will issue a Retrofit Failsafe Kit. In the meantime, please quarantine current stock of SmartBase products until the failsafe device has been fitted and tested.
• Distribution: PA, and worldwide
• Total Product Life Cycle: TPLC 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.