Sara Plus Active Floor Lift
This recall has been terminated (originally issued May 21, 2022).
- Recall Initiated
- April 5, 2022
- Posted
- May 21, 2022
- Terminated
- September 5, 2024
- Recall Number
- Z-1098-2022
- Quantity
- 4449 devices
- Official Source
- View on FDA website ↗
Reason for Recall
The device may emit smoke or ignite.
Distribution
US Nationwide and Worldwide distribution
Lot / Code Info
Model Numbers: HEP0001, HEP0001-AU, HEP0001-BR, HEP0001-CN, HEP0001-JP, HEP0001-UK, HEP0001-US, HEP1001, HEP1001-AU, HEP1001CON4869, HEP1001-US, HEP2001, HEP2001-BR, HEP2001-CN, HEP2001-UK
Root Cause
Device Design
Action Taken
A customer letter was sent to consignees on 04/08/2022. The customer are asked to acknowledge the notification, complete and sign off an enclosed Customer Response Form and return it to the local Arjo office (address indicated in the notification). The notification contains the list of precautionary measures to be taken by caregivers in order to minimize the likelihood of the failure until their lifts are corrected by Arjo. The device correction (including PCB upgrade and cover replacement) is to be performed by Arjo personnel, free of charge.