PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered

FDA device recall Z-0013-2018 · posted 2017-09-15 · Terminated

Recall details

Recalling firm

Handicare Usa Inc

Reason for recall

During internal cycle testing of A-Series lifts Handicare has found that the A-Series lift strap for lifts manufactured between April 25, 2017 and June 12, 2017 may wear prematurely at max load (625 lbs). We have identified the root cause as a supplied component that was not to specification. If the strap wears during use there is a potential risk for the person being supported by the lift to drop.

Action taken

The firm initiated their recall by email on 09/08/2017. The consignee was warned that the lift straps may wear prematurely and they would be contacted by a representative and the units would be replaced.

Root cause

Component design/selection

Status

Terminated

Product code

FSA

Quantity affected

8 units

Distribution

Us and Canada

Date initiated

2017-09-08

Date posted

2017-09-15

Date terminated

2018-12-17

Location

Maryland Heights, MO