Recall Z-2463-2012— Imaging Sciences International, LLC
Class II · Terminated
Class II FDA medical device recall by Imaging Sciences International, LLC, initiated 2012-07-30, terminated 2016-10-13. It names one FDA 510(k) clearance: K090461. Product: DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System. Reason: A condition can occur during renumbering of the patient database using the DEXCopy feature. When renumbering is being performed using the DEXCopy feature and multiple patients with an identical name are present, the software will assign all subsequent records to the first patient record, resulting in mixed patient records. In order for this problem to occur several conditions need to be met: 1).
- Recalling firm
- Imaging Sciences International, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-07-30
- Terminated
- 2016-10-13
- Firm location
- Hatfield, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System
Reason for recall
A condition can occur during renumbering of the patient database using the DEXCopy feature. When renumbering is being performed using the DEXCopy feature and multiple patients with an identical name are present, the software will assign all subsequent records to the first patient record, resulting in mixed patient records. In order for this problem to occur several conditions need to be met: 1)
Data sourced from openFDA. This site is unofficial and independent of the FDA.