KODAK DirectView DR 7100 System, Catalog # 133-6049. This is a digital radiology system. The major components are: opera
FDA device recall Z-0274-06 · posted 2005-12-08 · Terminated
Recall details
- Recalling firm
- Eastman Kodak Co
- Reason for recall
- 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.
- Action taken
- 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).
- Root cause
- Other
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 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 (g
- Date initiated
- 2005-10-20
- Date posted
- 2005-12-08
- Date terminated
- 2005-12-30
- Location
- Rochester, NY
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Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DR5000 DEDICATED CHEST X-RAY SYSTEM (K001341) | Analogic Corp. | 2000-06-02 |