Recall record at a glance
| Official record | Z-2652-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | ARJOHUNTLEIGH POLSKA SP. ZO.O. |
| Report date | Sep 24, 2014 |
| Recall initiation date | Jun 10, 2014 |
| Quantity | 382 lifts total worldwide (160 US) |
| Location | POZNAN, N/A, Poland |
Official product 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).
Why the product was recalled
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.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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