Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail…

Date

Sept. 22, 2021

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

Arjohuntleigh Magog, Inc.

Product

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.

Distribution pattern

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

Quantity

62 units

Codes and lots

All units of Model 700-00536: Class III 454 kg scale and Model 700-00526: 454 kg scale

Recall started

March 4, 2021

Device type

Lift, Patient, Non-Ac-Powered

Root cause (FDA)

Under Investigation by firm

What the company told customers

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.

Recall number

Z-2479-2021

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2479-2021. The agency record governs; check it and the company before acting.