FDA Medical Device Recalls (openFDA)
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 number
- Z-0731-2008
- Recalling firm
- Carestream Health, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2007-12-21
- Posted
- 2008-02-23
- Terminated
- 2008-04-10
- 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.
- Lot, serial or model codes
- Serial Numbers: 30000032, 30001001, 30001004, 30001006, 30001016, 30001020, 30001024, 30001036, 30001038, 30001040, 30001039, 30001042, 30001048, 30001043, 30001049, 30001044, 30001045, 30001046, 30001021.
- 510(k) numbers
- ["K060550"]
- PMA numbers
- not on file
- Product code
- KPR
- Firm FEI
- 1315356
- Firm city
- Rochester
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28