FDA recall, , Moderate risk
Intelerad IntelePACS Software
IntelePACS software has a cybersecurity vulnerability that could allow a malicious user to take over an administrator session.
Summary by Recall Canary from the FDA notice
What happened
Intelerad MEDICAL SYSTEMS INCORPORATED, based in Montreal, Canada, voluntarily recalled 560 Intelerad IntelePACS software platforms on September 10, 2026, after the FDA identified a cybersecurity vulnerability that could allow a malicious user to take over an administrator session, delete or modify image or study data, or lock legitimate users out of the system.
Additionally, a software issue has been identified that may result in the unintended deletion of image data from an external archive integration. The recall was added to the FDA's Enforcement Report on November 4, 2026, and customers were notified by e-mail.
The software was distributed in the United States in Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, and the District of Columbia, and in Australia, Canada, Ireland, New Zealand, South Africa, and the United Kingdom.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare these details with yours, then check the recall notice to see which units are recalled.
intelerad IntelePACS software
- Affected units
- HIBCC:B228INTELEPACS0/Affected versions: PACS-4-3-4-R20 PACS-4-9-1-R80 PACS-4-12-1-R81 through R90 PACS-4-14-1-R46 through R137 PACS-4-16-1-R50 through R137 PACS-4-17-1-R23 through R117 PACS-4-18-1-R31 through R91 PACS-5-1-1-R17 through R102 PACS-5-2-1-R36 through R93 PACS-5-3-1-R26 through R128 PACS-5-4-1-R15 through R101 PACS-5-5-1-R7 through R89 PACS-5-6-1-R12 through R81 PACS-5-7-1-R2 through R61 PACS-5-8-1-R2 through R42 PACS-5-9-1-R8 through R19
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Nov 2, 2026
- Sold in
- 39 states and DC
US: Alabama Florida Colorado Michigan California Texas Connecticut Arizona New Jersey Illinois North Carolina South Carolina Missouri New Hampshire Washington Kentucky Wyoming District of Columbia Nevada IN Pennsylvania Alaska OR Arkansas Kansas Tennessee Minnesota MD Iowa Wisconsin HI New York Ohio Virginia West Virginia New Mexico Georgia Louisiana Nebraska Utah Washington outside the U.S.: Australia , Canada, Ireland, New Zealand, South Africa, United Kingdom
- Recalled by
- INTELERAD MEDICAL SYSTEMS INCORPORATEDMontreal, Canada
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 99971
- Recall number
- Z-0357-2027
- Quantity recalled
- 560 software platforms
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
All recalls from INTELERAD MEDICAL SYSTEMS INCORPORATED
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
INTELERAD MEDICAL SYSTEMS INCORPORATED began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
