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U.S. Department of Health and Human Services

Class 2 Device Recall Entroy Pool Lift

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 Class 2 Recall
Entroy Pool Lift
see related information
Date Posted August 24, 2011
Recall Status1 Terminated on November 28, 2011
Recall Number Z-3070-2011
Recall Event ID 59588
Product Classification Lift, Patient, Non-Ac-Powered - Product Code FSA
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.
Code Information Model GAB1000-01-US, serial number SEE0326028 Rest of the world: Models GAB1000-01-xx, GAB1000-11-xx and GAC100x, all serial numbers
Recalling Firm/
Manufacturer
Arjo, Inc. dba ArjoHuntleigh
2349 W Lake St
Addison, Illinois 60101-6183
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: 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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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