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Recalls

Urgent Medical Device Field Correction: Merits Health Products Company, Ltd.

By July 29, 2022No Comments

About the Recall:

Merits Health Products has voluntarily initiated a field correction on the seat plates on selected power wheelchairs and scooters.

The potential is for the seat bracket to separate from the seat post resulting in the seat base separating suddenly without notice.

Merits Health Products is recalling these products after receiving three reports of separations associated with this issue. The failure rate is 0.12%, however, the company has expanded the field correction out of an abundance of caution.

How to Guide Patients:
Customers who contact AdaptHealth subsidiaries with questions must be informed to contact their provider to initiate the warranty order and to schedule the service and repair.

Customers should be instructed not to put any undue stress on the chair until this part has been upgraded. It is possible for the seat base to separate from the seat post. Should this happen, there could be potential for the user to lose balance and fall. Users may recognize the device may fail if there is any change in ride quality or if they hear an unusual noise. Should this occur, the patient should discontinue use and notify Merits Health Products at 239-772-0579.

Impacted customers will receive written notification of the field correction with instructions to report affected products and to arrange a visit from the provider to complete the repair. The field correction should take approximately 15 minutes to complete.

Actions to be Taken by the Provider:
Please contact Merits at 239-772-0579 to get a warranty order processed and mailed to you immediately. Providers should complete the repair as follows:

Replace the old seat plate with the new one provided using the SOP previously provided.
Complete and return the Service and Repair Report (sent with new part), inspect the installation, and note it on the appropriate Scooter or Power Chair Inspection Record provided.
Use the RA shipping label (sent with new part) and return old seat plate to Merits Health Products along with the Service and Repair Report (one filled out for each unit)
If you should need a copy of the SOP or the Service and Repair report sent to you, please email Merits Health Products Quality Assurance manager at: dcrostreet@meritsusa.com and it will be promptly emailed to you. Please state what you need.

If you have any other questions or issues, please contact your Merits Sales Representative.

Regarding Inventory:
Locations with this product on inventory are required to immediately pull it from shelves and quarantine it. Additional inventory handling instructions will be shared in the coming weeks, if applicable.