FDA Medical Device Recalls (openFDA)
Eastman Kodak Co: Kodak DirectView DR 7100 System, Catalog #133-6049, a digital radiology system. The major system components are: operator console; digital imaging capture device; tilting table with floating top; ceiling-mounted x-ray tube; x-ray generator timing and distribution unit.
- Recall number
- Z-0728-04
- Recalling firm
- Eastman Kodak Co
- Product
- Kodak DirectView DR 7100 System, Catalog #133-6049, a digital radiology system. The major system components are: operator console; digital imaging capture device; tilting table with floating top; ceiling-mounted x-ray tube; x-ray generator timing and distribution unit.
- Status
- Terminated
- Initiated
- 2004-02-20
- Posted
- 2004-07-20
- Terminated
- 2004-05-28
- Reason
- Defective component in overhead tube support balancer may cause the suspended load to fall.
- Root cause
- Other
- Action
- 2/20/2004: Field representatives notified the customer in China that the unit should not be used until the OTS Balancer component can be repaired/replaced.
- Quantity
- 3 units
- Distribution
- Amsterdam, China and Kuwait.
- Lot, serial or model codes
- Serial Numbers affected: 4193-5702, 4193-5704, 4193-5705, 4193-5706, 4193-5708
- 510(k) numbers
- ["K001341"]
- PMA numbers
- not on file
- Product code
- KPR
- Firm FEI
- 1315356
- Firm city
- Rochester
- Firm state
- NY
- 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