Recall Z-2267-2014 ยท LLZ System, Image Processing, Radiological
Intelerad Medical Systems
IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receives digital images and data from various sources (such as, CT scanners, MRI scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources.
| Date | Aug 19, 2014 (initiated Jul 3, 2014) |
| Status | Terminated |
| Reason | In specific situation a partially truncated file may be written to the IntelePACS server. This partially truncated file still can be viewed by InteleViewer and InteleViewer will report to the user that the file in question is complete. This situation only occurs if a file is partially truncated. |
| Root cause | Software design |
| Action | Intelerad sent an Urgent Recall for Product Correction letter to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that a new software release will be installed on the system. Afterwards, an audit will be run on the the entire PACS to identify all image data that may have been truncated. Customers were requested to complete and return the attached Client Response Form. |
| Quantity | 230 |
| Distribution | Worldwide Distribution - USA Nationwide and the countries of Scotland, Ireland, United Kingdom, Canada, Australia, and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083520 | INTELEPACS, MODEL VERSION 3.X.X Intelerad Medical Systems Incorporated, Jun 23, 2009 |