Kodak DirectView Model DR 3000 System, Stationary X-ray System; Catalog #s 6551360, 6551386, 6552152, 6552160, 6551345,
FDA device recall Z-0731-2008 · posted 2008-02-23 · Terminated
Recall details
- Recalling firm
- Carestream Health, Inc.
- Reason for recall
- Unintended Positioner Movement - The U-Arm Positioner starts to move 1) without command from the operator and/or 2) can unexpectedly start movement if the system is powered down and re-energized after a collision has occurred with the Quantum Table.
- Action taken
- On 12/21/07, Service Bulletins (dated December 2007) were sent to consignees informing them of design modification, and providing modification instructions. The firm followed up with telephone calls to the direct user sites to schedule appointments to visit each site, in order to make the necessary modifications. The firm will be installing Safety Adaptation Board and software into all the affected DR3000 systems.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- Domestic - 19 units
- Distribution
- Nationwide Distribution including states of NY, PA, MA, MI, IL, NC, GA, FL, KS, MO, TX, IA, and WA.
- Date initiated
- 2007-12-21
- Date posted
- 2008-02-23
- Date terminated
- 2008-04-10
- Location
- Rochester, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386 (K060550) | Eastman Kodak Company | 2006-03-31 |