Z-1036-04

Advance Medical''s, The Closed Camera System, 9'' x 96'' (23cm x 244cm), REF 04-CC900, Lot 40475C4144...

Name: Z-1036-04 Advance Medical''s, The Closed Camera System, 9'' x 96'' (23cm x 244cm), REF 04-CC900, Lot 40475C4144...
Creator: Advance Medical Designs Inc
Published: 2004-06-18
License: https://open.fda.gov/license/

Advance Medical Designs Inc / initiated 2004-06-18 / Terminated

FDA source

Advance Medical Designs Inc began a recall of 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... on 2004-06-18. The reason FDA records is "The product may come apart when excessive force is applied to the coupler". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1036-04
Status: Terminated
Initiated: 2004-06-18
Posted: 2004-07-20
Terminated: 2004-09-03
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.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: The product may come apart when excessive force is applied to the coupler.
FDA 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 in commerce: 2340 units, *amended to include additional 250 units
Distribution: Nationwide and Canada
Product codes and lots: Product #04-CC900, Lot #40475C4144 and 40474C4148 *amend to include 40494C4154

Product code JAA

K850959Class IIEquipment Snap KoversAdvance Medical Designs, Inc. / cleared 1985-04-09

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)