Minstrel (with scale) Product Usage: is a mobile passive hoist. It is intended for lifting and...

FDA Device Recall #Z-2693-2014 — Class II — July 28, 2014

Recall Summary

Recall Number Z-2693-2014
Classification Class II — Moderate risk
Date Initiated July 28, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Location KOMORNIKI, N/A
Product Type Devices
Quantity 18 Lifts

Product Description

Minstrel (with scale) Product Usage: is a mobile passive hoist. It is intended for lifting and transporting adult residents on horizontal floors in hospitals, nursing homes or other health care facilitates. The Minstrel device aids in the lifting, transfer and lowering to safe position, of a patient. This is accomplished by placing a sling under the patient, and attaching the sling to a spreader bar that is connected to a lifting arm jig via a connection to the spreader bar that allows a swiveling up-down movement. Using battery power, an actuator then powers the lifting arm upwards so that the patient in the sling is lifted from, typically, a bed or chair.

Reason for Recall

ArjoHuntleigh received three reports where the bolt under the scale unscrewed from the scale. There is a remote risk concerning the bolt unscrewing from the scale. When the scale and bolt parts are not correctly serviced, or when they receive a sharp blow during or outside of use, it is possible the bolt holding the spreader bar to the scale could unscrew during subsequent use. As a result, the sp

Distribution Pattern

Worldwide Distribution - US Nationwide in the state of MA and the countries of Australia, Germany, and Italy.

Lot / Code Information

Model Numbers: HMA0002 and HMB002-US; Serial Numbers: MPLAT0409W1177 ; MPLAT0410W1213 ; MPLAT0410W1228 ; MPLAT0410W1229 ; MPLAT0410W1231 ; MPLAT0410W1232 ; MPLAT0412W1290 ; MPLAT0412W1296 ; MPLAT0412W1297 ; MPLAT0502W1403 ; MPLAT0502W1404 ; MPLAT0503W1485 ; MPLAT0503W1486 ; MPLAT0504W1518 ; MPLAT0504W1519 ; MPLAT0504W1520 ; MPLAT0504W1531

Other Recalls from ARJOHUNTLEIGH POLSKA Sp. z.o.o.

Recall # Classification Product Date
Z-0611-2024 Class II Arjo medical beds, Models Enterprise 5000X, Ent... Aug 29, 2023
Z-0612-2024 Class II Arjo medical beds, Models Enterprise 5000X, Ent... Aug 29, 2023
Z-1098-2022 Class I Sara Plus Active Floor Lift Apr 5, 2022
Z-2588-2021 Class II Arjo Citadel beds originally assembled with the... Jun 10, 2021
Z-2821-2020 Class II Bariatric Bed Frame System The Citadel Plus ... Jul 21, 2020

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.