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U.S. Department of Health and Human Services

Class 2 Device Recall Maxi Sky 1000 and BHM Medical V10 Bariatric Ceiling Lift

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 Class 2 Recall
Maxi Sky 1000 and BHM Medical V10 Bariatric Ceiling Lift
see related information
Date Posted April 14, 2011
Recall Status1 Terminated on February 16, 2012
Recall Number Z-1983-2011
Recall Event ID 58048
Product Classification Lift, Patient, Non-Ac-Powered - Product Code FSA
Product Maxi Sky 1000/BHM Medical V10 Bariatric Ceiling Lift System; a patient transfer lift; ArjoHuntleigh, Addison, IL 60101; Model numbers LF20010, LF20011, LF20013, LF20014, LF20015, LF21015, LF21019, 9120001, 9120004, 9120005, 9120008, 9120009 and 9121009 The Maxi Sky 1000 is designed for lifting patients in a homecare setting, at nursing homes and other assisted living centers, as well as in institutional or hospital settings. Patient transferring is performed under the supervision of an appropriately trained caregiver staff, in accordance with the instructions for use. All other uses must be avoided.
Code Information Model numbers LF20010, LF20011, LF20013, LF20014, LF20015, LF21015, LF21019, 9120001, 9120004, 9120005, 9120008, 9120009 and 9121009. All serial numbers manufactured prior to February 1, 2011.
Recalling Firm/
Manufacturer
Arjo, Inc. dba ArjoHuntleigh
2349 W Lake St
Addison, Illinois 60101-6183
Manufacturer Reason
for Recall
The battery-powered control board in the ceiling lift motor may overheat, resulting in smoke and possibly flames and the lift becoming inoperable.
FDA Determined
Cause 2
DESIGN: Device Design
Action ArjoHuntleigh sent an Urgent Field Safety Notice dated March 4, 2011, to all affected customers via UPS Ground on March 21, 2011. The notice informed the accounts of the potential for smoke and flames coming out of the Maxi Sky 1000/V10 bariatric ceiling lifts. The accounts were requested to immediately cease use of the affected lifts, powering them down by activating the emergency stop, and tag the lifts to prevent further use. If there is a clinical need to continue use of the lift before it is retrofitted or replaced, specific instructions were given to reduce the risk of a device malfunction. The accounts were requested to complete the Customer Response Form online, using the enclosed card's instructions. Questions were directed to the ArjoHuntleigh at 1-800-323-1245, ext 57985.
Quantity in Commerce 1,246 units
Distribution Nationwide Distribution
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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