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.
FDA Recall Z-0731-2008 · Posted 2008-02-23
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Recalling FirmCarestream Health, Inc.
Recall StatusTerminated
Product CodeKPR
Date Initiated2007-12-21
Date Terminated2008-04-10
Product QuantityDomestic - 19 units
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution including states of NY, PA, MA, MI, IL, NC, GA, FL, KS, MO, TX, IA, and WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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