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U.S. Department of Health and Human Services

Class 2 Device Recall Maxi Sky 1000 (Arjo) and V10 (BHM)

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  Class 2 Device Recall Maxi Sky 1000 (Arjo) and V10 (BHM) see related information
Date Initiated by Firm March 04, 2021
Create Date September 16, 2021
Recall Status1 Terminated 3 on January 12, 2024
Recall Number Z-2479-2021
Recall Event ID 88435
Product Classification Lift, patient, non-ac-powered - Product Code FSA
Product Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with measuring function
Code Information All units of Model 700-00536: Class III 454 kg scale and Model 700-00526: 454 kg scale
Recalling Firm/
Manufacturer		 Arjohuntleigh Magog, Inc.
2001 Tanguay St
Magog Canada
Manufacturer Reason
for Recall		 The spreader bar can disconnect from the scale bottom attachment.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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