Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2479-2021Class II

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

Arjohuntleigh Magog, Inc. / initiated 2021-03-04 / Terminated

Arjohuntleigh Magog, Inc. began a recall of Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with measuring function on . FDA classified it as Class II and gives the reason as "The spreader bar can disconnect from the scale bottom attachment". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-2479-2021
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Arjohuntleigh Magog, Inc.
Product
Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with measuring function
Product code
FSA Lift, Patient, Non-Ac-Powered
Reason for recall
The spreader bar can disconnect from the scale bottom attachment.
FDA root cause
Under Investigation by firm
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.
Quantity in commerce
62 units
Distribution
Distribution in US - AZ, CA, CO, IL, LA, MA, MI, MO, OH, PA, WA
Product codes and lots
All units of Model 700-00536: Class III 454 kg scale and Model 700-00526: 454 kg scale

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2479-2021
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2479-2021Class IITerminatedVoluntary: Firm initiated