Device product

EasyStand Bantam, with the following sizes. a. Small; b. Extra Small. Used for assisting individual in standing.

Z-0243-2023

October 04, 2022

Class II

Product summary

Firm: Altimate Medical, Inc.
Event: Event 91002
Status: Terminated
Classification: Class II
Quantity: 14 devices
Official record key: device-enforcement:Z-0243-2023

Official wording

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.

Code information: a. UDI: (01)10858921006062(21)V2005693010, (01)10858921006062(21)V2005693012, (01)10858921006062(21)V2005693015, (01)10858921006062(21)V2005693017, (01)10858921006062(21)V2005694003, (01)10858921006062(21)V2005694009, (01)10858921006062(21)V2005694020, (01)10858921006062(21)V2005695010, (01)10858921006062(21)V2005695011, (01)10858921006062(21)V2005695018, (01)10858921006062(21)V2005695019, (01)10858921006062(21)V2005695020; b. UDI: (01)10858921006079(21)V1005700003, (01)10858921006079(21)V1005700009

Distribution pattern: Worldwide - US distribution in the states of CA, CT, FL, LA, MI, TN, TX and the country of Canada.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.