- Recalling firm
- INTELERAD MEDICAL SYSTEMS INCORPORATED
- Reason for recall
- Following a Chromium-based web-browser, report and displayed images may not match.
- Affected products (lot / model / serial)
- Identifier Number PACS-5-1-1-R102, HIBC Number +B228INTELEPACS0/$75-1-1-R102C; Identifier Number PACS-5-2-1-R93, HIBC Number +B228INTELEPACS0/$75-2-1-R93M; Identifier Number PACS-5-3-1-R117, HIBC Number +B228INTELEPACS0/$75-3-1-R117K; Identifier Number PACS-5-3-1-R128, HIBC Number +B228INTELEPACS0/$75-3-1-R128M; Identifier Number PACS-5-3-1-R83, HIBC Number +B228INTELEPACS0/$75-3-1-R83M; Identifier Number PACS-5-4-1-R101, HIBC Number +B228INTELEPACS0/$75-4-1-R101E; Identifier Number PACS-5-4-1-R75, HIBC Number +B228INTELEPACS0/$75-4-1-R75O; Identifier Number PACS-5-4-1-R75, HIBC Number +B228INTELEPACS0/$75-4-1-R75O; Identifier Number PACS-5-4-1-R75, HIBC Number +B228INTELEPACS0/$75-4-1-R75O; Identifier Number PACS-5-4-1-R82, HIBC Number +B228INTELEPACS0/$75-4-1-R82M; Identifier Number PACS-5-4-1-R84, HIBC Number +B228INTELEPACS0/$75-4-1-R84O; Identifier Number PACS-5-4-1-R91, HIBC Number +B228INTELEPACS0/$75-4-1-R91M; Identifier Number PACS-5-5-1-R50, HIBC Number +B228INTELEPACS0/$75-5-1-R50I; Identifier Number PACS-5-5-1-R53, HIBC Number +B228INTELEPACS0/$75-5-1-R53L; Identifier Number PACS-5-5-1-R60, HIBC Number +B228INTELEPACS0/$75-5-1-R60J; Identifier Number PACS-5-6-1-R40, HIBC Number +B228INTELEPACS0/$75-6-1-R45N; Identifier Number PACS-5-6-1-R43, HIBC Number +B228INTELEPACS0/$75-6-1-R43L; Identifier Number PACS-5-6-1-R44, HIBC Number +B228INTELEPACS0/$75-6-1-R44M; Identifier Number PACS-5-6-1-R52, HIBC Number +B228INTELEPACS0/$75-6-1-R52L; Identifier Number PACS-5-6-1-R52, HIBC Number +B228INTELEPACS0/$75-6-1-R52L; Identifier Number PACS-5-6-1-R52, HIBC Number +B228INTELEPACS0/$75-6-1-R52L; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$75-6-1-R57Q; Identifier Number PACS-5-6-1-R58, HIBC Number +B228INTELEPACS0/$75-6-1-R58R; Identifier Number PACS-5-6-1-R58, HIBC Number +B228INTELEPACS0/$75-6-1-R58R; Identifier Number PACS-5-6-1-R58, HIBC Number +B228INTELEPACS0/$75-6-1-R58R; Identifier Number PACS-5-6-1-R59, HIBC Number +B228INTELEPACS0/$75-6-1-R59S; Identifier Number PACS-5-6-1-R59, HIBC Number +B228INTELEPACS0/$75-6-1-R59S; Identifier Number PACS-5-6-1-R60, HIBC Number +B228INTELEPACS0/$75-6-1-R60K; Identifier Number PACS-5-6-1-R60, HIBC Number +B228INTELEPACS0/$75-6-1-R60K; Identifier Number PACS-5-6-1-R62, HIBC Number +B228INTELEPACS0/$75-6-1-R62M; Identifier Number PACS-5-6-1-R62, HIBC Number +B228INTELEPACS0/$75-6-1-R62M; Identifier Number PACS-5-6-1-R62, HIBC Num
- Units affected
- 317 units
- Distribution pattern
- US Nationwide distribution.
- Firm location
- Montreal, Canada
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0186-2027
- Recall initiated
- September 5, 2026
- FDA classification date
- October 15, 2026
- FDA report date
- October 21, 2026
- FDA event ID
- 99899
- Last updated on HTM Vibe
- October 27, 2026
