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.
FDA Recall Z-1216-2010 · Posted 2010-03-31
Recall StatusTerminated
Product CodeFNM
Date Initiated2010-03-05
Date Terminated2012-03-21
Product Quantity349
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide distribution: CA, TX, IN, OR, and MO.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.