Class 2 Device Recall ArjoHuntleigh

• Date Initiated by Firm: July 28, 2014
• Date Posted: September 24, 2014
• Recall Status: Terminated on September 13, 2016
• Recall Number: Z-2693-2014
• Recall Event ID: 68594
• Product Classification: Lift, patient, non-ac-powered - Product Code FSA
• 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.
• 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
• Recalling Firm/ Manufacturer: ARJOHUNTLEIGH POLSKA Sp. z.o.o.; UI. KS. PIOTRA WAWRZYNIAKA 2; KOMORNIKI Poland
• For Additional Information Contact: 800-323-1245 Ext. 57985
• Manufacturer 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
• FDA Determined Cause: Device Design
• Action: 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.
• Quantity in Commerce: 18 Lifts
• Distribution: Worldwide Distribution - US Nationwide in the state of MA and the countries of Australia, Germany, and Italy.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.