Sara Plus Active Floor Lift
FDA device recall Z-1098-2022 · posted 2022-05-21 · Terminated
Recall details
- Recalling firm
- ARJOHUNTLEIGH POLSKA Sp. z.o.o.
- Reason for recall
- The device may emit smoke or ignite.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FSA
- Quantity affected
- 4449 devices
- Distribution
- US Nationwide and Worldwide distribution
- Date initiated
- 2022-04-05
- Date posted
- 2022-05-21
- Date terminated
- 2024-09-05
- Location
- Komorniki, Poland
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