A-series lift - A625 Manual Part No. 324117. Prism Medical.

FDA Device Recall #Z-1406-2017 — Class II — January 30, 2017

Recall Summary

Recall Number Z-1406-2017
Classification Class II — Moderate risk
Date Initiated January 30, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm ErgoSafe Products, LLC (DBA) Prism Medical
Location Maryland Heights, MO
Product Type Devices
Quantity 76

Product Description

A-series lift - A625 Manual Part No. 324117. Prism Medical.

Reason for Recall

During internal cycle test at max load (625 lbs.) 2 units had straps break prematurely.

Distribution Pattern

Product was distributed to MT and NV; one VA consignee.

Lot / Code Information

A6MC000016 A6MC000019 A6MC000020 A6MC000021 A6MC000022 A6MC000023 A6MC000024 A6MC000025 A6MC000026 A6MC000027 A6MC000028 A6MC000029 A6MC000030 A6MC000031 A6MC000009 A6MC000002 A6MC000004 A6MC000001 A6MC000003 A6MC000005 A6MC000006 A6MC000007 A6MC000008 A6MC000010 A6MC000011 A6MC000012 A6MC000013 A6MC000014 A6MC000015 A6MC000017 A6MC000018 A6MC000096 A6MC000087 A6MC000088 A6MC000090 A6MC000091 A6MC000092 A6MC000093 A6MC000094 A6MC000048 A6MC000068 A6MC000070 A6MC000072 A6MC000073 A6MC000074 A6MC000075 A6MC000078 A6MC000079 A6MC000081 A6MC000082 A6MC000083 A6MC000085 A6MC000086 A6MC000042 A6MC000043 A6MC000045 A6MC000046 A6MC000047 A6MC000049 A6MC000050 A6MC000051 A6MC000052 A6MC000053 A6MC000054 A6MC000055 A6MC000056 A6MC000057 A6MC000058 A6MC000059 A6MC000060 A6MC000061 A6MC000062 A6MC000063 A6MC000064 A6MC000066 A6MC000071

Other Recalls from ErgoSafe Products, LLC (DBA) Prism Me...

Recall # Classification Product Date
Z-1405-2017 Class II A-series lift - A625 Manual w/Load Cell & Wi-Fi... Jan 30, 2017
Z-0728-2017 Class II Carry bar which is an accessory to a lift used ... Aug 30, 2016
Z-0285-2016 Class II Prism Medical P-300 Portable Consumer Lift; PN ... Sep 8, 2015
Z-0284-2016 Class II Prism Medical C-300 Consumer Ceiling Lift; PN 3... Sep 8, 2015
Z-2269-2015 Class II Prism Medical P-440 Portable Ceiling Lift; PN 3... Jun 24, 2015

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.