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U.S. Department of Health and Human Services

Class 2 Device Recall Milford Smartbase

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  Class 2 Device Recall Milford Smartbase see related information
Date Initiated by Firm March 07, 2018
Create Date April 18, 2018
Recall Status1 Open3, 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 2
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.
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