FDA Medical Device Recalls (openFDA)
Arjo, Inc.: ARJO,Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient lift; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden
- Recall number
- Z-0261-2008
- Recalling firm
- Arjo, Inc.
- Product
- ARJO,Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient lift; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden
- Status
- Terminated
- Initiated
- 2007-10-15
- Posted
- 2007-12-01
- Terminated
- 2009-07-27
- Reason
- Male patient genitals may be pinched between the seat and the frame of the patient lift chair when the Care Raiser seat is returned to its lowest position.
- Root cause
- Device Design
- Action
- Arjo sent Customer Field Correction Notification letters dated 10/15/07 to the end user accounts who received the affected chairs, advising them of the potential for the pinching of male patient genitals between moving parts of the care raiser function of the Carendo Hygiene Chair. They were instructed to review the enclosed revised Operating and Product Care Instructions manual, highlighting the warnings on pages 18 and 20; ensure all users receive refresher training in the chair's proper use and have access to the revised manual; and complete and return the enclosed customer response form, acknowledging the receipt and understanding of the letter. Any questions were directed to the Arjo Quality Department at 800-323-1245, ext. 6140 or 6165.
- Quantity
- 1,342 hygiene chairs
- Distribution
- Nationwide
- Lot, serial or model codes
- Model BIB2003-01, All Serial Numbers
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FSA
- Firm FEI
- 1419652
- Firm city
- Roselle
- Firm state
- IL
- Firm country
- not on file
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