Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-3070-2011

Entroy Pool Lift; a patient lift used in conjunction with a chair or stretcher to lift them in/out of a...

Arjo, Inc. / initiated 2011-08-04 / Terminated / root cause: design

Arjo, Inc. dba ArjoHuntleigh began a recall of Entroy Pool Lift; a patient lift used in conjunction with a chair or stretcher to lift them in/out of a swimming/therapy pool; Arjo Hospital Equipment AB... on . The reason FDA records is "The Entroy Pool Lift boom may rapidly lower un-commanded to the bottom of its stroke, with a potential for injury to the resident or caregiver". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-3070-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Arjo, Inc.
Product
Entroy Pool Lift; a patient lift used in conjunction with a chair or stretcher to lift them in/out of a swimming/therapy pool; Arjo Hospital Equipment AB, Eslov, Sweden; Models GAB1000-01-xx, GAB1000-11-xx and GAC100x Entroy is a pool lift that docks to either a chair or a stretcher and aids disabled people getting in and out of a pool. This equipment is intended for disabled persons who need to transfer in and out of a therapy and swimming pool under supervision of skilled and trained personnel in accordance with the Entroy Operating and Product Care Instructions. All other use must be avoided. Active/semi-active persons can and should use the Entroy chair (with or without chassis) while bedridden persons without trunk stability can and should be transferred with the Entroy stretcher with chassis.
Product code
FSA Lift, Patient, Non-Ac-Powered
Reason for recall
The Entroy Pool Lift boom may rapidly lower un-commanded to the bottom of its stroke, with a potential for injury to the resident or caregiver.
Root cause tag
design
FDA root cause
Device Design
Action
ArjoHuntleigh sent an Urgent Field Correction Notice I.D. 110701AHE to the affected end user via UPS 2nd Day on August 4, 2011. The notice informed the account of the potential for lift boom to rapidly lower un-commanded to the bottom of its stroke. The account was requested to immediately cease use of the affected lift, and disconnect the power to the lift to prevent further use until corrected. The account was requested to complete and sign the Customer Response Form, and return it to ArjoHuntleigh to schedule a service call to correct the lift. Questions were directed to the ArjoHuntleigh at 1-800-323-1245, ext 54485.
Quantity in commerce
1 unit in the U.S., 311 units in the rest of the world
Distribution
Worldwide Distribution - USA including CT
Product codes and lots
Model GAB1000-01-US, serial number SEE0326028  Rest of the world: Models GAB1000-01-xx, GAB1000-11-xx and GAC100x, all serial numbers