FDA Recall Terminated

Tenor is a mobile passive lift, intended to be used on horizontal surfaces for lifting and transfer in hospitals, nursing homes or other healthcare facilities. Transfers with the Tenor are made indoors in the patient's room, in communal areas or in a bathroom. Tenor is meant to be used with the patient type who: sits in a wheelchair, has no capability to support themselves at all, cannot stand unsupported and is not able to bear weight (not even partially), is dependent on caregiver in most situations, is a passive resident, might be almost completely bed ridden, is often stiff and has contracted joints, and/or is totally dependent. The Tenor has a safe working load of 320 KG (705 lbs).

Recall: Z-2652-2014 · Initiated June 10, 2014

Recall

Recall Number
Z-2652-2014
Event Number
68113
Firm
ARJOHUNTLEIGH POLSKA SP. ZO.O. UI. KS. WAWRZYNIAKA 2 KOMORNIKI POZNAN Poland
FEI Number
3007420694
Product Code
FSA
Status
Terminated
Root Cause
Device Design
Initiated
June 10, 2014
Posted
September 16, 2014
Terminated
June 20, 2018

Description

Tenor is a mobile passive lift, intended to be used on horizontal surfaces for lifting and transfer in hospitals, nursing homes or other healthcare facilities. Transfers with the Tenor are made indoors in the patient's room, in communal areas or in a bathroom. Tenor is meant to be used with the patient type who: sits in a wheelchair, has no capability to support themselves at all, cannot stand unsupported and is not able to bear weight (not even partially), is dependent on caregiver in most situations, is a passive resident, might be almost completely bed ridden, is often stiff and has contracted joints, and/or is totally dependent. The Tenor has a safe working load of 320 KG (705 lbs).

Reason

ArjoHuntleigh received reports where the Tenor Lift without Scale (spreader bar) bolt broke during use. There is a remote risk concerning the breakage of the spreader bar bolt connection, part # TEN.018. During use, the bolt is subjected to mechanical forces, which may lead to breakage.

Action

ArjoHuntleigh sent an URGENT - FIELD SAFETY NOTICE letter dated June 10, 2014, to all affected customers. The letter included instructions for direct accounts to: 1) ensure that caregivers and users of the Tenor patient transfer lift referenced above are made aware of the field safety notice; 2) ensure that a copy of the field safety notice is placed in the Tenor Lift Instructions for Use manual for future reference and training; 3) complete and sign the enclosed Customer Response Form and return the form to the ArjoHuntleigh Regulatory Department; 4) and to be advised that an ArjoHuntleigh Service Technician will contact the facility representative listed on the Customer Response Form to schedule service to replace your spreader bar, free of charge. Customers with questions about this recall can contact ArjoHuntleigh at 800-323-1245 x 57985 or via e-mail at [email protected].

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to Australia, Bahrain, Canada, France, Germany, India, Ireland, Israel, Italy, Mexico, Netherlands, New Zealand, Poland, Romania, Saudi Arabia, South Africa, Spain, Sweden, United Kingdom, and Uruguay.

Quantity

382 lifts total worldwide (160 US)