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

FDA device recall Z-2693-2014 · posted 2014-09-24 · Terminated

Recall details

Recalling firm

ARJOHUNTLEIGH POLSKA Sp. z.o.o.

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

Action taken

ARJOHUNTLEIGH sent an URGENT - FIELD SAFETY NOTICE letter dated July 28, 2014 to all customers. The letter identified the affected product, problem and actions to be taken. The letters provided customers with two options with how to address this recall: 1) because the devices are close to their 10-year lifetime, customers can return the devices for a trade-in discount that will be applied to the purchase of a new ArjoHuntleigh patient transfer lift; or 2) an ArjoHuntleigh Service Technician will install a new scale with added locking features to the existing unit free of charge. Customers were further instructed to: 1) ensure that all caregivers and users of the devices are given a copy of the letter; 2) place a copy of this letter with the device's instruction for use; and, 3) to complete and return the enclosed Customer Service Response form. For questions or assistance completing the Customer Response Form, please contact ArjoHuntleigh at 1-800-323-1245, ext. 57985 during office hours; Monday to Friday, 8:00am to 5:00pm (CST) or via email at AHNA-RA@arjohuntleigh.com.

Root cause

Device Design

Status

Terminated

Product code

FSA

Quantity affected

18 Lifts

Distribution

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

Date initiated

2014-07-28

Date posted

2014-09-24

Date terminated

2016-09-13

Location

KOMORNIKI, Poland