FDA Recall Terminated

Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with measuring function

Recall: Z-2479-2021 · Initiated March 4, 2021

Recall

Recall Number
Z-2479-2021
Event Number
88435
Firm
Arjohuntleigh Magog, Inc.
FEI Number
3002655016
Product Code
FSA
Status
Terminated
Root Cause
Under Investigation by firm
Initiated
March 4, 2021
Terminated
January 12, 2024
Address
2001 Tanguay St, Magog Canada

Description

Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with measuring function

Reason

The spreader bar can disconnect from the scale bottom attachment.

Action

Customers identified as owners of the affected scales will be notified of the identified product risk and the Field Safety Corrective Action through the Field Safety Notice. Affected customers need to ensure that all caregivers and users of the affected devices are made aware of the Field Safety Notice. There will be two options for customers: - Contact Arjo to order parts and instruction required to proceed with the disconnection of the affected scale by on-site biomed personnel to continue to use the ceiling lift safely, or - Contact Arjo to ask to an Arjo service technician to visit a customer facility to perform the scale disconnection to continue to use the ceiling lift safely. The Field Safety Notice will be accompanied by Customer Response Form. Following its return to the local Arjo office and the availability of the permanent solution, a customer will be contacted to complete the action.

Distribution

Distribution in US - AZ, CA, CO, IL, LA, MA, MI, MO, OH, PA, WA

Quantity

62 units