Recall Z-0026-2007 ยท FNL Bed, Ac-Powered Adjustable Hospital
Extended Care Air Therapy Systems Inc
ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed
| Date | Oct 14, 2006 (initiated Apr 5, 2006) |
| Status | Terminated |
| Reason | Component defect- Following assembly and distribution, two (2) bolts may bend in the bed frame, which may allow the bed to tip into the wall |
| Root cause | Other |
| Action | The firm sent a Product Advisory Letter to their distributor/customers on 4/5/2006. The letter instructs the distributors as to the correct way to handle the beds during movement, loading, and unloading onto delivery trucks. The letter also urges the distributors to inspect the bed frame units in inventory at their locations for the presence of any bending, or damage to the four frame bolts. The letter states that the company will replace the bolts as soon as possible when ever necessary. |
| Quantity | 102 beds |
| Distribution | The recalled medical beds were distributed to six (6) wholesale/distributor customers located in the following states: KS, TN, MI, PA, and LA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.