Z-0013-2018Class II

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

Name: Z-0013-2018 PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Creator: Handicare Usa Inc
Published: 2017-09-08
License: https://open.fda.gov/license/

Handicare USA, Inc. / initiated 2017-09-08 / Terminated / root cause: design

FDA source

Handicare Usa Inc began a recall of PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered on 2017-09-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0013-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-08
Posted: 2017-09-15
Terminated: 2018-12-17
Recalling firm: Handicare USA, Inc.
Product: PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Product code: FSA Lift, Patient, Non-Ac-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.
Root cause tag: design
FDA root cause: Component design/selection
Action: 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.
Quantity in commerce: 8 units
Distribution: Us and Canada
Product codes and lots: A6M0001526, A6M0001527, A6M0001528, A6M0001529, A6M0001530, A6M0001485, A6M0001486, A6M0001498

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0013-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0013-2018	Class II	Terminated	Voluntary: Firm initiated	2017-10-18	2017-10-06

Product code FSA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)