Z-1172-2007

Non-AC-powererd Patient Lifts for assisting patients when bathing and toileting-sold under names "Bath...

Name: Z-1172-2007 Non-AC-powererd Patient Lifts for assisting patients when bathing and toileting-sold under names "Bath...
Creator: The Sisus Corporation
Published: 2007-06-01
License: https://open.fda.gov/license/

The Sisus Corporation / initiated 2007-06-01 / Terminated / root cause: design

FDA source

The Sisus Corporation began a recall of Non-AC-powererd Patient Lifts for assisting patients when bathing and toileting-sold under names "Bath Helper" and "Shower Helper" , Sisus Corporation, Santa... on 2007-06-01. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1172-2007
Status: Terminated
Initiated: 2007-06-01
Posted: 2007-08-17
Terminated: 2008-08-19
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.
Product code: FSA Lift, Patient, Non-Ac-Powered
Reason for recall: 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 tag: design
FDA 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 in commerce: 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.
Product codes and lots: 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.

Product code FSA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)