FDA Medical Device Recalls (openFDA)
ARJOHUNTLEIGH POLSKA Sp. z.o.o.: Sara Plus Active Floor Lift
- Recall number
- Z-1098-2022
- Recalling firm
- ARJOHUNTLEIGH POLSKA Sp. z.o.o.
- Product
- Sara Plus Active Floor Lift
- Status
- Terminated
- Initiated
- 2022-04-05
- Posted
- 2022-05-21
- Terminated
- 2024-09-05
- Reason
- The device may emit smoke or ignite.
- Root cause
- Device Design
- 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.
- Quantity
- 4449 devices
- Distribution
- US Nationwide and Worldwide distribution
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FSA
- Firm FEI
- 3007420694
- Firm city
- Komorniki
- Firm state
- not on file
- Firm country
- Poland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28