FDA-Device2012-07-18Class II
Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Products N.V., Heikant 5, B-3930 Hamont-Achel, Belgium; Models HEP0001-US and HEP1001-US. The Sara Plus is a standing and raising aid for short transfers e.g. raising from bed and transfer to wheelchair, or from wheelchair to toilet. Sara Plus is also suitable for walking training when the footboard and kneepad are removed.
Arjo, Inc. dba ArjoHuntleigh
Hazard
ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an exposed metal support bracket when the proactive knee pad assembly is removed.
Sold states
Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Belgium, Bermuda, Canada, Cyprus, Czech Republic, Denmark, Dubai, Estonia, Finland, France, Germany, Gibraltar, Great Britain, Greece, Hong Kong, Iceland, Ireland, Israel, Italy, Japan, Kenya, Korea, Luxembourg, the Netherlands, New Zealand, Northern Ireland, Norway, Poland, Portugal, Quatar, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland and Turkey
Affected count
2480 units in U.S., 2,651 units in the rest of the world
Manufactured in
2349 W Lake St, Addison, IL, United States
Products
Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Products N.V., Heikant 5, B-3930 Hamont-Achel, Belgium; Models HEP0001-US and HEP1001-US. The Sara Plus is a standing and raising aid for short transfers e.g. raising from bed and transfer to wheelchair, or from wheelchair to toilet. Sara Plus is also suitable for walking training when the footboard and kneepad are removed.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1949-2012Don't want to check this manually?
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