FDA Medical Device Recalls (openFDA)
Eastman Kodak Co: KODAK DirectView DR 7100 System, Catalog # 133-6049. This is a digital radiology system. The major 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-0274-06
- Recalling firm
- Eastman Kodak Co
- Product
- KODAK DirectView DR 7100 System, Catalog # 133-6049. This is a digital radiology system. The major 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
- 2005-10-20
- Posted
- 2005-12-08
- Terminated
- 2005-12-30
- Reason
- Potential weld defect in the Overhead Tube Support assembly which connects the tube assembly to the telescoping arm. This could cause the tube assembly to fall, injuring anyone near the unit.
- Root cause
- Other
- Action
- Letters dated 10/20/2005 were hand carried by Kodak Field Service Reps. Kodak Field Engineers inspected units and found the two defective units (both in China).
- Quantity
- 3
- Distribution
- DOMESTIC: 12 units shipped to 12 medical facilities in FL, KY, MI, NY, OH, PA, and SC. FOREIGN: 12 units shipped to 7 hospitals in China, 1 warehouse in China; 1in the possession of Chinese Customs (government); and 1 is in a warehouse in Russia.
- Lot, serial or model codes
- s/n DR71000121 and DR71000123.
- 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