Z-1943-2020 Class II Ongoing

Recalled by Handicare AB — Lulea, N/A

FDA device recall Z-1943-2020 was initiated by Handicare AB on June 15, 2016 and is designated Class II. Reason for recall: After feedback from customers and internal suspicion, Handicare has become aware that abnormal use of Eva-lifts could lead to a deterioation in the joint of the liftarm. This could lead to injury if t… The recall status is ongoing. Affected quantity: 997 units.

Recall Details

Product Type
Devices
Report Date
May 20, 2020
Initiation Date
June 15, 2016
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
997 units

Product Description

EVA Floor Lifts, Model Numbers: 400, 450, 600

Reason for Recall

After feedback from customers and internal suspicion, Handicare has become aware that abnormal use of Eva-lifts could lead to a deterioation in the joint of the liftarm. This could lead to injury if the joint breaks. All lifts must therefore be checked and reported back to the manuafacturer.

Distribution Pattern

US and Mexico

Code Information

All affected models