IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receives digital images and data
FDA device recall Z-2267-2014 · posted 2014-08-19 · Terminated
Recall details
- Recalling firm
- Intelerad Medical Systems
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 230
- Distribution
- Worldwide Distribution - USA Nationwide and the countries of Scotland, Ireland, United Kingdom, Canada, Australia, and New Zealand.
- Date initiated
- 2014-07-03
- Date posted
- 2014-08-19
- Date terminated
- 2016-01-13
- Location
- Montreal, Canada
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTELEPACS, MODEL VERSION 3.X.X (K083520) | Intelerad Medical Systems Incorporated | 2009-06-23 |