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Terminated

Sara Plus Active Floor Lift

FDA Recall Z-1098-2022 · Posted 2022-05-21

Recalling FirmARJOHUNTLEIGH POLSKA Sp. z.o.o.
Recall StatusTerminated
Product CodeFSA
Date Initiated2022-04-05
Date Terminated2024-09-05
Product Quantity4449 devices

Reason for Recall

The device may emit smoke or ignite.

Firm Action

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

Distribution Pattern

US Nationwide and Worldwide distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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