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.
This recall has been terminated (originally issued April 14, 2011).
- Company
- Arjo, Inc. Dba Arjohuntleigh
- Recall Initiated
- March 21, 2011
- Posted
- April 14, 2011
- Terminated
- February 16, 2012
- Recall Number
- Z-1983-2011
- Quantity
- 1,246 units
- Firm Location
- Addison, IL
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution
Lot / Code Info
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.
Root Cause
Device Design
Action Taken
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.