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U.S. Department of Health and Human Services

Class 2 Device Recall EncompassTSS

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 Class 2 Recall
EncompassTSS
see related information
Date Posted March 31, 2010
Recall Status1 Terminated on March 21, 2012
Recall Number Z-1216-2010
Recall Event ID 55074
Product Classification Mattress, Air Flotation, Alternating Pressure - Product Code FNM
Product AccuMax Quantum Complete (Model CU3/CU4), an alternating pressure with turn assist & on demand low air loss system; Encompass Therapuetic Support Systems, Glendale, CA. The device is intended to treat or prevent decubitus ulcers, extensive burns, urinary tract blockage and to aid circulation.
Code Information Serial No: 6101, 6170 and 6267-6613
Recalling Firm/
Manufacturer
Encompass Therapeutic Support Systems dba BG North America
500 N Central Ave Ste 900
Glendale, California 91203-3346
Manufacturer Reason
for Recall
Potential out gasing of the battery and short term ignition of the gas within the control unit enclosure. This failure mode includes a risk for fire.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action An "URGENT RECALL NOTIFICATION" letter dated March 5, 2010, was sent to the customers. The letter describes the product, problem and action to be taken by the customers. The customers should immediately discontinue use of the control unit, turn off the unit and disconnect from the wall socket and quarantine the unit away from any patient's room. The customers should immediately examine your inventory and quarantine the products listed; identify and notify any facility where they may have further distributed or transferred the listed products; and complete and return the REPLY/FAX-BACK FORM as soon as possible to Fax: (626) 796-7856 or mail to EncompassTSS, 100 E. Corson Street, Ste 310, Pasadena, CA 91103. Please contact EncompassTSS Customer Service at 800-822-8288 if you have any questions regarding this recall notice.
Quantity in Commerce 349
Distribution Nationwide distribution: CA, TX, IN, OR, and MO.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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