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U.S. Department of Health and Human Services

Class 2 Device Recall "Shower Helper" and "Bath Helper"

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  Class 2 Device Recall "Shower Helper" and "Bath Helper" see related information
Date Initiated by Firm June 01, 2007
Date Posted August 17, 2007
Recall Status1 Terminated 3 on August 19, 2008
Recall Number Z-1172-2007
Recall Event ID 38096
Product Classification Patient Lifts - Product Code FSA
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.
Code Information 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.
Recalling Firm/
Manufacturer		 The Sisus Corporation
721 30th Ave
Santa Cruz CA 95062-5070
For Additional Information Contact Simon Kaiwai
415-235-0558
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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