Recall Z-2693-2014 ยท FSA Lift, Patient, Non-Ac-Powered
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
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
| Date | Sep 24, 2014 (initiated Jul 28, 2014) |
| Status | Terminated |
| 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 |
| Root 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 wer |
| Quantity | 18 Lifts |
| Distribution | Worldwide Distribution - US Nationwide in the state of MA and the countries of Australia, Germany, and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.