Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with measuring function
Summary
The FDA issued a Class II for Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with me by Arjohuntleigh Magog, Inc.. Reason: The spreader bar can disconnect from the scale bottom attachment..
Details
Source
Device Recall
External ID
Z-2479-2021
Action Date
2021-09-22
Status
Terminated
Category
device
Product Description
Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with measuring function
Lot/Code Info: All units of Model 700-00536: Class III 454 kg scale and Model 700-00526: 454 kg scale
Quantity Affected: 62 units
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
Type: Voluntary: Firm initiated
Recall Initiated: 2021-03-04
Company
Magog, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 142 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Arjohuntleigh Magog, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Arjohuntleigh Magog, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Arjohuntleigh Magog, Inc. have FDA actions?
Arjohuntleigh Magog, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2479-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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