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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Carestream Health, Inc.
Lot Codes / Batch Numbers
Serial Numbers: 30000032, 30001001, 30001004, 30001006, 30001016, 30001020, 30001024, 30001036, 30001038, 30001040, 30001039, 30001042, 30001048, 30001043, 30001049, 30001044, 30001045, 30001046, 30001021.
Products Sold
Serial Numbers: 30000032, 30001001, 30001004, 30001006, 30001016, 30001020, 30001024, 30001036, 30001038, 30001040, 30001039, 30001042, 30001048, 30001043, 30001049, 30001044, 30001045, 30001046, 30001021.
Carestream Health, Inc. is recalling Kodak DirectView Model DR 3000 System, Stationary X-ray System; Catalog #s 6551360, 6551386, 6552152 due to Unintended Positioner Movement - The U-Arm Positioner starts to move 1) without command from the operator and/or 2) can unexpectedly start movement if. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026