Recall Z-2652-2014 ยท FSA Lift, Patient, Non-Ac-Powered
ARJOHUNTLEIGH POLSKA SP. ZO.O.
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 uns
| Date | Sep 16, 2014 (initiated Jun 10, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| 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 S |
| Quantity | 382 lifts total worldwide (160 US) |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.