Z-1216-2010

AccuMax Quantum Complete (Model CU3/CU4), an alternating pressure with turn assist & on demand low air loss...

Name: Z-1216-2010 AccuMax Quantum Complete (Model CU3/CU4), an alternating pressure with turn assist & on demand low air loss...
Creator: Encompass Therapeutic Support Systems dba BG North America
Published: 2010-03-05
License: https://open.fda.gov/license/

Encompass Therapeutic Support Systems dba BG North America / initiated 2010-03-05 / Terminated / root cause: manufacturing process

FDA source

Encompass Therapeutic Support Systems dba BG North America began a recall of AccuMax Quantum Complete (Model CU3/CU4), an alternating pressure with turn assist & on demand low air loss system; Encompass Therapuetic Support Systems... on 2010-03-05. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1216-2010
Status: Terminated
Initiated: 2010-03-05
Posted: 2010-03-31
Terminated: 2012-03-21
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.
Product code: FNM Mattress, Air Flotation, Alternating Pressure
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 349
Distribution: Nationwide distribution: CA, TX, IN, OR, and MO.
Product codes and lots: Serial No: 6101, 6170 and 6267-6613

Product code FNM

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)