A-series lift - A625 Manual w/Load Cell & Wi-Fi, Omni Part No. 324124. Prism Medical.
FDA Device Recall #Z-1405-2017 — Class II — January 30, 2017
Recall Summary
| Recall Number | Z-1405-2017 |
| 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 | 21 |
Product Description
A-series lift - A625 Manual w/Load Cell & Wi-Fi, Omni Part No. 324124. 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
A6MC000110 A6M0001010 A6M0001011 A6M0001012 A6M0001013 A6M0001014 A6M0001015 A6M0001016 A6M0001017 A6M0001018 A6M0001019 A6M0001020 A6M0001021 A6M0001025 A6M0001026 A6M0001029 A6M0001022 A6M0001023 A6M0001024 A6M0001027 A6M0001028
Other Recalls from ErgoSafe Products, LLC (DBA) Prism Me...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1406-2017 | Class II | A-series lift - A625 Manual Part No. 324117. Pr... | 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.