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U.S. Department of Health and Human Services

Class 2 Device Recall Kodak DirectView DR 3000 System

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 Class 2 Recall
Kodak DirectView DR 3000 System
see related information
Date Posted February 23, 2008
Recall Status1 Terminated on April 10, 2008
Recall Number Z-0731-2008
Recall Event ID 46266
Premarket Notification
510(K) Number
K060550 
Product Classification System, X-Ray, Stationary - Product Code KPR
Product 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.
Code Information Serial Numbers: 30000032, 30001001, 30001004, 30001006, 30001016, 30001020, 30001024, 30001036, 30001038, 30001040, 30001039, 30001042, 30001048, 30001043, 30001049, 30001044, 30001045, 30001046, 30001021.
Recalling Firm/
Manufacturer
Carestream Health, Inc.
150 Verona Street
Rochester, New York 14608-1733
For Additional Information Contact Ms. Christine E. Ehmann
585-724-4487
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: 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 in Commerce Domestic - 19 units
Distribution Nationwide Distribution including states of NY, PA, MA, MI, IL, NC, GA, FL, KS, MO, TX, IA, and WA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPR and Original Applicant = EASTMAN KODAK COMPANY
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