ClearanceBrief
Recall Z-1629-2023 ยท FSA Lift, Patient, Non-Ac-Powered

Arjohuntleigh Magog, Inc.

Arjo Portable Scale Adaptor, Model Number 700.05725; accessory intended to be used in combination with compatible patient lifting equipment

DateMay 24, 2023 (initiated Feb 17, 2023)
StatusOpen, Classified
ReasonSome Arjo Portable Scale Adaptors have been assembled with straps that have a potential to detach.
Root causeProcess control
ActionArjo issue an URGENT MEDICAL DEVICE RECALL notice to its consignees on 02/17/2023 via letter, UPS, 2nd Day Delivery. The notice explained the problem, the risk, and requested the consignee remove the units from use and destroy them. The firm will be replacing the units upon receipt of the completed response form. For questions or assistance in completing the Customer Response Form, please contact Arjo at 1 800-323-1245 or via email at ArjoCustomer.Response-US@arjo.com.
Quantity3
DistributionUS: OH, NY
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.