Recall Z-0243-2023 ยท INO Chair, Positioning, Electric
Altimate Medical, Inc.
EasyStand Bantam, with the following sizes. a. Small; b. Extra Small. Used for assisting individual in standing.
| Date | Nov 16, 2022 (initiated Oct 4, 2022) |
| Status | Terminated |
| Reason | Some EasyStand Bantam Small and Extra Small standers with the non-supine option may have been manufactured with a component that affects the operation of the leg assembly bracket to maintain the standers non-supine position. |
| Root cause | Pending |
| Action | Altimate Medical notified consignees via email on about 10/04/2022. The email contained a letter which instructed consignees to examine unit on hand to determine if it is affected, contact Customer Service if assistance is needed determining if unit is affected, cease distribution or use of affected device, replace bracket and confirm unit is corrected and functioning properly by returning the provided verification document. |
| Quantity | 14 devices |
| Distribution | Worldwide - US distribution in the states of CA, CT, FL, LA, MI, TN, TX and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091242 | BANTAM Altimate Medical, Inc., Jul 6, 2009 |