Recall Z-0880-2023 ยท INN Chair, Adjustable, Mechanical
Altimate Medical, Inc.
ActiveAid 922, Shower/Commode Chair
| Date | Jan 4, 2023 (initiated Nov 30, 2022) |
| Status | Terminated |
| Reason | Device manufactured with a component with affects the foldability of the frame, not allowing it to be secured by the frame strap in the folded position. |
| Root cause | Component change control |
| Action | Altimate Medical notified its sole consignee by telephone on 11/30/2022 and followed with an Urgent Medical Device Recall letter on 12/06/2022. The notice stated the problem and requested the following action: "- Acknowledge receipt of this notification. Complete and return the attached Acknowledgement form. - Inform the customer not to use the chair if this has not already done. - Provide replacement chair 90071504001 under RMA000737 to AMI - Inform Altimate when the replacement chair is provided to the customer. Complete and return the attached Verification form." |
| Quantity | 1 unit |
| Distribution | US Nationwide distribution in the state of Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.