Recall Z-1216-2010 ยท FNM Mattress, Air Flotation, Alternating Pressure
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.
| Date | Mar 31, 2010 (initiated Mar 5, 2010) |
| Status | Terminated |
| 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 |
| Quantity | 349 |
| Distribution | Nationwide distribution: CA, TX, IN, OR, and MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.