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Terminated

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

FDA Recall Z-2479-2021 · Posted None

Recalling FirmArjohuntleigh Magog, Inc.
Recall StatusTerminated
Product CodeFSA
Date Initiated2021-03-04
Date Terminated2024-01-12
Product Quantity62 units

Reason for Recall

The spreader bar can disconnect from the scale bottom attachment.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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