FDA Medical Device Recalls (openFDA)
The Sisus Corporation: Non-AC-powererd Patient Lifts for assisting patients when bathing and toileting-sold under names "Bath Helper" and "Shower Helper" , Sisus Corporation, Santa Cruz, CA 95062.
- Recall number
- Z-1172-2007
- Recalling firm
- The Sisus Corporation
- Product
- Non-AC-powererd Patient Lifts for assisting patients when bathing and toileting-sold under names "Bath Helper" and "Shower Helper" , Sisus Corporation, Santa Cruz, CA 95062.
- Status
- Terminated
- Initiated
- 2007-06-01
- Posted
- 2007-08-17
- Terminated
- 2008-08-19
- Reason
- Poor welding may cause the device(s) to fail, which may result in the user, falling in the bathroom and/or a lack of assistance with bathing or toileting.
- Root cause
- Device Design
- Action
- On 6/8/2007, a letter was sent to all dealers and each direct account customer/user followed by a phone call to ensure the notification letter was received. Customers were instructed to discontinue use of the devices pending receipt of modification kits/ instructions to be shipped priority overnight. The firm plans to call customers/dealers to support them with the installations and ensure smooth implementation. Dealers were instructed to conduct recall to the user level.
- Quantity
- approximately 100 units have been distributed.
- Distribution
- Nationwide Distribution including states of PA, TX, NY, MI, AL, FL, CA, OH, CT, WA, MD, OR, NC, NH, VT, IL, CO, HI, LA, GA, TN, OK, MA, KS, SC, ME, GA, MN, IN, and DE.
- Lot, serial or model codes
- The "Shower Helper" may be identified as Model SBH10.0 or as "Sisus All In One". The "Bath Helper" is identified as Model SBB10.0.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FSA
- Firm FEI
- 3005798859
- Firm city
- Santa Cruz
- Firm state
- CA
- 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