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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2479-2021 | Class II | Terminated | Voluntary: Firm initiated |
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