Recall Z-0731-2008 ยท KPR System, X-Ray, Stationary
Carestream Health, Inc.
Kodak DirectView Model DR 3000 System, Stationary X-ray System; Catalog #s 6551360, 6551386, 6552152, 6552160, 6551345, 6552319, 6552335. The units are labeled under the following firms: EASTMAN KODAK COMPANY (now known as Carestream Heath Inc.) Rochester, NY 14608, or CARESTREAM HEALTH, INC., Rochester, NY 14608.
| Date | Feb 23, 2008 (initiated Dec 21, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | Domestic - 19 units |
| Distribution | Nationwide Distribution including states of NY, PA, MA, MI, IL, NC, GA, FL, KS, MO, TX, IA, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060550 | KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386 Eastman Kodak Company, Mar 31, 2006 |