Class II recall Z-0186-2027: INTELERAD MEDICAL SYSTEMS INCORPORATED
Class II recall Z-0186-2027: INTELERAD MEDICAL SYSTEMS INCORPORATED: INTELERAD MEDICAL SYSTEMS INCORPORATED. Dated 14 days ago, it is in the active follow-up window. Score 68/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Free preview: all 14 published fields of this record are shown below. Locked: 499 related FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0186-2027 |
| Recalling firm | INTELERAD MEDICAL SYSTEMS INCORPORATED |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | IntelePACS, InteleConnect Portal/Tech Portal Versions PACS-5-1-1-R102, PACS-5-2-1-R93, PACS-5-3-1-R83 through R128, PACS-5-4-1-R66 through R101, PACS-5-5-1-R50 through R89, PACS-5-6-1-R41 through R81, PACS-5-7-1-R21 through R61, PACS-5-8-1-R2 through R42, PACS-5-9-1-R8 through R19; System, Image Processing, Radiological |
| Reason | Following a Chromium-based web-browser, report and displayed images may not match. |
| Quantity | 317 units |
| Distribution | US Nationwide distribution. |
| Recall initiated | 2026-09-05 |
| Reported | 2026-10-21 |
| Firm location | Montreal, Canada |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-21
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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68 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 14 days ago.
What is the FDAPulse record for Class II recall Z-0186-2027: INTELERAD MEDICAL SYSTEMS INCORPORATED?
Class II device recall Z-0186-2027 by INTELERAD MEDICAL SYSTEMS INCORPORATED: Following a Chromium-based web-browser, report and displayed images may not match.
How does Class II recall Z-0186-2027: INTELERAD MEDICAL SYSTEMS INCORPORATED compare to other FDAPulse records?
It is fresh: dated 14 days ago, inside the window where early outreach matters most.
Class II recall Z-0186-2027 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-0186-2027 | 2026-10-21 | |
| Class II recall Z-3155-2026 | MA | 2026-10-07 |
| Class II recall Z-0232-2027 | 2026-10-28 | |
| Class II recall Z-0243-2027 | 2026-10-28 |
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