Recall Z-2693-2014— ARJOHUNTLEIGH POLSKA Sp. z.o.o.

Class II FDA medical device recall by ARJOHUNTLEIGH POLSKA Sp. z.o.o., initiated 2014-07-28, terminated 2016-09-13. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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.

Recalling firm

ARJOHUNTLEIGH POLSKA Sp. z.o.o.

Classification

Class II

Status

Terminated

Initiated

2014-07-28

Terminated

2016-09-13

Firm location

KOMORNIKI, N/A, Poland

Data sourced from openFDA. This site is unofficial and independent of the FDA.