Arjo Tenor patient lift actuators may lose the ability to hold load
Arjo Tenor mobile passive patient lifts are being recalled because an internal actuator component in one production batch may not meet the required mechanical strength.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where an actuator may fail to hold a patient's weight, a risk of harm with no injuries reported in the source.
Plain-English summary
Arjo is recalling the Tenor mobile passive patient lift, model numbers KHA1000 US and KHA1010 US. The action covers 119 units, identified by the serial numbers listed in the recall notice.
An internal component of the actuators in a certain production batch may not meet the required mechanical strength. According to the manufacturer, this could result, in the worst case, in a sudden loss of the actuator's ability to hold the load, leading to rapid and uncontrolled downward movement of the lifting arm. The FDA classified the action as Class II.
Distribution was nationwide in the United States. The lifts are supplied to care settings for moving patients rather than sold to consumers.
Facilities should identify affected units using the model numbers, UDI-DI codes and serial numbers in the recall notice and follow the instructions issued by Arjo.
The recalled product
- Product
- Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
- Manufacturer
- ARJOHUNTLEIGH POLSKA Sp. z.o.o.
- Category
- Medical Device — Patient lift
- Affected units
- 119
Distribution
Distributed nationwide across the United States.
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