FDA Medical Device Recalls (openFDA)
Intelerad Medical Systems Inc.: IntelePACS Picture Archiving Communications System InteleViewer Workstation Model #3.X.X.
- Recall number
- Z-1884-2009
- Recalling firm
- Intelerad Medical Systems Inc.
- Product
- IntelePACS Picture Archiving Communications System InteleViewer Workstation Model #3.X.X.
- Status
- Terminated
- Initiated
- 2008-10-27
- Posted
- 2009-08-27
- Terminated
- 2010-09-24
- Reason
- Product software versions 3.5.2.P1 to 3.5.2.p56 inclusive and 3.6.1.P1 to 3.6.1.P82 inclusive were defective.
- Root cause
- Software design
- Action
- Intelerad Medical Systems issued an Urgent Medical Device Filed Safety Notice" dated October 24, 2008 describing the affected product and steps required for system upgrade. Users are requested to complete and return an acknowledgement form via email to quality@intelerad.com. For further information, contact Intelerad Medical Systems at 1-514-931-6222.
- Quantity
- 1
- Distribution
- Worldwide Distribution -- United States (NM, AZ, CT, MN, TX, NC, TN, FL and CO), Canada, Australia, and New Zealand.
- Lot, serial or model codes
- InteleViewer software versions 3.5.2.P1 to 3.3.2.P56 inclusive and 3.6.1.P1 to 3.6.1.P82 inclusive.
- 510(k) numbers
- ["K070080"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3003768392
- Firm city
- Montreal
- Firm state
- not on file
- Firm country
- Canada
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