Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with measuring function
This recall has been terminated (originally issued March 4, 2021).
- Company
- Arjohuntleigh Magog, Inc.
- Recall Initiated
- March 4, 2021
- Terminated
- January 12, 2024
- Recall Number
- Z-2479-2021
- Quantity
- 62 units
- Firm Location
- Magog Canada
- Official Source
- View on FDA website ↗
Reason for Recall
The spreader bar can disconnect from the scale bottom attachment.
Distribution
Distribution in US - AZ, CA, CO, IL, LA, MA, MI, MO, OH, PA, WA
Lot / Code Info
All units of Model 700-00536: Class III 454 kg scale and Model 700-00526: 454 kg scale
Root Cause
Under Investigation by firm
Action Taken
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.