FDA Medical Device Recalls (openFDA)
Encompass Therapeutic Support Systems dba BG North America: 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.
- Recall number
- Z-1216-2010
- Recalling firm
- Encompass Therapeutic Support Systems dba BG North America
- 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.
- Status
- Terminated
- Initiated
- 2010-03-05
- Posted
- 2010-03-31
- Terminated
- 2012-03-21
- Reason
- 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.
- Root cause
- 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
- 349
- Distribution
- Nationwide distribution: CA, TX, IN, OR, and MO.
- Lot, serial or model codes
- Serial No: 6101, 6170 and 6267-6613
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FNM
- Firm FEI
- 3002468793
- Firm city
- Glendale
- 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