FDA Medical Device Recalls (openFDA)
Advance Medical Designs Inc: Advance Medical''s, The Closed Camera System, 9'' x 96'' (23cm x 244cm), REF 04-CC900, Lot 40475C4144, Sterile, Manufactured by Advance Medical Designs, Inc., 1241 Atlanta Industrial Drive, Marietta, GA 80066 USA.
- Recall number
- Z-1036-04
- Recalling firm
- Advance Medical Designs Inc
- Product
- Advance Medical''s, The Closed Camera System, 9'' x 96'' (23cm x 244cm), REF 04-CC900, Lot 40475C4144, Sterile, Manufactured by Advance Medical Designs, Inc., 1241 Atlanta Industrial Drive, Marietta, GA 80066 USA.
- Status
- Terminated
- Initiated
- 2004-06-18
- Posted
- 2004-07-20
- Terminated
- 2004-09-03
- Reason
- The product may come apart when excessive force is applied to the coupler.
- Root cause
- Other
- Action
- Consignees were notified on 6/17/2004 first by telephone on 6/17/2004 with f/u letter sent 6/18/04.
- Quantity
- 2340 units, *amended to include additional 250 units
- Distribution
- Nationwide and Canada
- Lot, serial or model codes
- Product #04-CC900, Lot #40475C4144 and 40474C4148 *amend to include 40494C4154
- 510(k) numbers
- ["K850959"]
- PMA numbers
- not on file
- Product code
- JAA
- Firm FEI
- 1037885
- Firm city
- Marietta
- Firm state
- GA
- 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