Recall Z-0738-2007 ยท KPR System, X-Ray, Stationary
Carestream Health, Inc.
Kodak Direct View DR7500 System, Catalog #s 855-1046, 879-1345, 161-9139 --- A stationary X-Ray System. Device Listing # E222512.
| Date | Jun 30, 2007 (initiated Mar 6, 2007) |
| Status | Terminated |
| 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 |
| Quantity | Domestic: 28 units |
| Distribution | Nationwide: CO, IL, MI, MN, MS, NY, OK, PA, SC, TN, WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051258 | KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345 Eastman Kodak Company, Jun 1, 2005 |