Class II recall Z-3155-2026: Philips North America Llc
Class II recall Z-3155-2026: Philips North America Llc (Massachusetts): Philips North America Llc. Dated 28 days ago, it is in the active follow-up window. Score 70/100. As of 2026-11-03, 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-3155-2026 |
| Recalling firm | Philips North America Llc |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | FDA Mandated |
| Specialty | Other |
| Product | Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333 |
| Reason | The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional radiation. |
| Quantity | 62 |
| Distribution | U.S. and U.S. Territories. |
| Recall initiated | 2026-08-18 |
| Reported | 2026-10-07 |
| Firm location | Cambridge, MA, United States |
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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: 2026-10-07
- Data refreshed: 2026-11-03
- 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: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: Class II recall Z-3155-2026: Philips North America Llc 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)
70 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- FDA-mandated rather than firm-initiated.
- Posted 28 days ago.
What is the FDAPulse record for Class II recall Z-3155-2026: Philips North America Llc in Massachusetts?
Class II device recall Z-3155-2026 by Philips North America Llc: The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur eve
How does Class II recall Z-3155-2026: Philips North America Llc compare to other Massachusetts FDAPulse records?
It is 28 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 70/100 puts it among the stronger signals in this feed.
Class II recall Z-3155-2026 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| 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 | |
| Class II recall Z-0258-2027 | 2026-10-28 |
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