Z-1405-2017Class II

A-series lift - A625 Manual w/Load Cell & Wi-Fi, Omni Part No. 324124. Prism Medical

Name: Z-1405-2017 A-series lift - A625 Manual w/Load Cell & Wi-Fi, Omni Part No. 324124. Prism Medical
Creator: ErgoSafe Products, LLC (DBA) Prism Medical
Published: 2017-01-30
License: https://open.fda.gov/license/

Handicare USA, Inc. / initiated 2017-01-30 / Terminated / root cause: design

FDA source

ErgoSafe Products, LLC (DBA) Prism Medical began a recall of A-series lift - A625 Manual w/Load Cell & Wi-Fi, Omni Part No. 324124. Prism Medical on 2017-01-30. FDA classified it as Class II and gives the reason as "During internal cycle test at max load (625 lbs.) 2 units had straps break prematurely". 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-1405-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-30
Posted: 2017-02-28
Terminated: 2017-12-04
Recalling firm: Handicare USA, Inc.
Product: A-series lift - A625 Manual w/Load Cell & Wi-Fi, Omni Part No. 324124. Prism Medical.
Product code: FSA Lift, Patient, Non-Ac-Powered
Reason for recall: During internal cycle test at max load (625 lbs.) 2 units had straps break prematurely.
Root cause tag: design
FDA root cause: Device Design
Action: The recalling firm called each customer on Jan 30, 2017 to review the recall and schedule a time for the firm to come to their facility to personally swap the recalled product for a new device. The FSNs were sent on Jan 31, 2017.
Quantity in commerce: 21
Distribution: Product was distributed to MT and NV; one VA consignee.
Product codes and lots: A6MC000110 A6M0001010 A6M0001011 A6M0001012 A6M0001013 A6M0001014 A6M0001015 A6M0001016 A6M0001017 A6M0001018 A6M0001019 A6M0001020 A6M0001021 A6M0001025 A6M0001026 A6M0001029 A6M0001022 A6M0001023 A6M0001024 A6M0001027 A6M0001028

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1405-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1405-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-03
Z-1406-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-03

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)