FDA Medical Device Recalls (openFDA)
Carestream Health, Inc.: Kodak Direct View DR7500 System, Catalog #s 855-1046, 879-1345, 161-9139 --- A stationary X-Ray System. Device Listing # E222512.
- Recall number
- Z-0738-2007
- Recalling firm
- Carestream Health, Inc.
- Product
- Kodak Direct View DR7500 System, Catalog #s 855-1046, 879-1345, 161-9139 --- A stationary X-Ray System. Device Listing # E222512.
- Status
- Terminated
- Initiated
- 2007-03-06
- Posted
- 2007-06-30
- Terminated
- 2007-06-29
- Reason
- The x-ray systems do not indicate the field size when the system's detector is turned off and the collimator is in manual mode. This results in the systems being noncompliant with the field indication performance standards of section 1020.31(e)(2)& (3) of 21Code of Federal Regulations (CFR).
- Root cause
- Other
- Action
- On 2/21/07, Eastman Kodak notified CDRH of its proposed Corrective Action Plan CAP). The CAP was approved by CDRH under the following conditions: (1) Kodak will visit each user facility, and apply dial indicator labels to the collimator knobs, apply a field size label to the collimator housing, and verify that each system complies with the field indication performance standard. (2) Kodak will prepare adequate instructions for the assembly/installation and testing of the dial indicators labels and field size labels. These instructions are to be furnished to all owners of the Kodak Direct View DR 7500 Systems. (3) Kodak will supplement the Kodak DR 7500 system product report with a copy of the adequate instructions. (4) Kodak will perform 100% verification of the recall effectiveness. (5) Kodak will not charge for the corrections and will reimburse the owner for any out-of-pocket expenses. (6) Kodak will notify the manufacturer of the Ralco 302 ACS collimators, Ralco, that the collimator is noncompliant with the performance standard. Kodak has reported that the CAP was completed as of 5/07/07.
- Quantity
- Domestic: 28 units
- Distribution
- Nationwide: CO, IL, MI, MN, MS, NY, OK, PA, SC, TN, WA
- Lot, serial or model codes
- Serial Numbers DR75000103, DR75000110, DR75000123, DR75000125, DR75000126, DR75000129, DR75000133, DR75000134, DR75000135, DR75000138, DR75000139, DR75000141, DR75000144, DR75000145, DR75000147, DR75000202, DR75000203, DR75000205, DR75000206, DR75000210, DR75000213, DR75000219, DR75000220, DR75000221, DR75000232, DR75000250, DR75000252, DR75000258.
- 510(k) numbers
- ["K051258"]
- PMA numbers
- not on file
- Product code
- KPR
- Firm FEI
- 1317307
- 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