Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1420-2018Class II

Product: Milford Smartbase Model # 9934105 Pride SmartBase Pride product codes: LSMPLCG A & LSMPLCG B

Autochair / initiated 2018-03-07 / Open, Classified / root cause: design

Autochair began a recall of Product: Milford Smartbase Model # 9934105 Pride SmartBase Pride product codes: LSMPLCG A & LSMPLCG B on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number
Z-1420-2018
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Autochair
Product
Product: Milford Smartbase Model # 9934105 Pride SmartBase Pride product codes: LSMPLCG A & LSMPLCG B
Product code
FSA Lift, Patient, Non-Ac-Powered
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.
Root cause tag
design
FDA root 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
Product codes and lots
All Lots

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1420-2018
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1420-2018Class IIOngoingVoluntary: Firm initiated