FDA recall Z-0013-2018

Product

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

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.

Distribution

Us and Canada

Key facts

Status

Terminated

Initiation date

2017-09-08

Report date

2017-10-18

Termination date

2018-12-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Maryland Heights, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0013-2018