FDA Medical Device Recalls (openFDA)
Extended Care Air Therapy Systems Inc: ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed
- Recall number
- Z-0026-2007
- Recalling firm
- Extended Care Air Therapy Systems Inc
- Product
- ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed
- Status
- Terminated
- Initiated
- 2006-04-05
- Posted
- 2006-10-14
- Terminated
- 2012-09-21
- 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.
- Lot, serial or model codes
- Serial Numbers: E9084 - E9094 & E10001 - E10099. The serial # is found at the bottom of the stick on label. The label is affixed to the foot of the bed frame on the right hand side.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FNL
- Firm FEI
- 3002498894
- Firm city
- Roseville
- Firm state
- OH
- 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