Class II recall Z-3312-2026: Philips North America
Class II recall Z-3312-2026: Philips North America (Massachusetts): Philips North America. Dated 29 days ago, it is in the active follow-up window. Score 62/100. 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: 40 related MA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3312-2026 |
| Recalling firm | Philips North America |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; Software Versions: R11, R12 and R13; |
| Reason | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction. |
| Quantity | 131 |
| Distribution | Worldwide distribution - Nationwide and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Equator. Guinea, Finland, France, French Guiana, Georgia, Germany, Ghana, Gree |
| Recall initiated | 2026-08-28 |
| Reported | 2026-10-07 |
| Firm location | Cambridge, MA, United States |
| Peer records CSV (41 MA records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-07
- 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 21:30:53 GMT
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Peer benchmark and outreach value: Class II recall Z-3312-2026: Philips North America and 41 Massachusetts peers
- Massachusetts FDAPulse records like this one: 41
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Massachusetts peer: $8,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
62 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 29 days ago.
What is the FDAPulse record for Class II recall Z-3312-2026: Philips North America in Massachusetts?
Class II device recall Z-3312-2026 by Philips North America: When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports con
How does Class II recall Z-3312-2026: Philips North America compare to other Massachusetts FDAPulse records?
It is 29 days old, still within a typical 45-day follow-up window.
Class II recall Z-3312-2026 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-3312-2026 | MA | 2026-10-07 |
| 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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