Device recall: Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146
Class II FDA enforcement event 96889. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Philips North America Llc started this device recall on 13 May 2025. The firm address in the FDA record is in Cambridge, MA. FDA put the recall in Class II. FDA event 96889 has 18 product records. The first FDA enforcement report date is 28 May 2025. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Côte D'Ivoire, Cyprus, Czech Republic, Denmark, Finland,…
Recalling firm
Philips North America Llc, Cambridge, MA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
18 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1788-2025 | Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146 | 80 units (1 US, 79 OUS) | Class II | Ongoing | 28 May 2025 |
| Z-1789-2025 | Product Name: SmartPath to dStream for 3.0T; Model Number: 782145 | 12 units (OUS only) | Class II | Ongoing | 28 May 2025 |
| Z-1790-2025 | Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113; | 55 units (2 US, 53 OUS) | Class II | Ongoing | 28 May 2025 |
| Z-1791-2025 | Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144; | 16 units (All OUS) | Class II | Ongoing | 28 May 2025 |
| Z-1792-2025 | Product Name: Upgrade to MR 7700; Model Number: 782130; | 13 units (7 US, 6 OUS) | Class II | Ongoing | 28 May 2025 |
| Z-1793-2025 | Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148; | 52 units (3 US, 49 OUS) | Class II | Ongoing | 28 May 2025 |
| Z-1794-2025 | Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143; | 28 units (5 US, 23 OUS) | Class II | Ongoing | 28 May 2025 |
| Z-1795-2025 | Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140; | 264 units (46 US, 218 OUS) | Class II | Ongoing | 28 May 2025 |
| Z-1796-2025 | Product Name: Ingenia 1.5T S; Model Number: 781347; | 2 units (US Only) | Class II | Ongoing | 28 May 2025 |
| Z-1797-2025 | Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103; | 193 units (36 US, 157 OUS) | Class II | Ongoing | 28 May 2025 |
| Z-1798-2025 | Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139; | 152 units (25 US, 127 OUS) | Class II | Ongoing | 28 May 2025 |
| Z-1799-2025 | Product Name: Ingenia 1.5T CX; Model Number: 781262; | 9 units (OUS Only) | Class II | Ongoing | 28 May 2025 |
| Z-1800-2025 | Product Name: Ingenia 3.0T CX; Model Number: 781271; | 37 units (OUS Only) | Class II | Ongoing | 28 May 2025 |
| Z-1801-2025 | Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138; | 300 units (81 US, 219 OUS) | Class II | Ongoing | 28 May 2025 |
| Z-1802-2025 | Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137; | 65 units (6 US, 59 OUS) | Class II | Ongoing | 28 May 2025 |
| Z-1803-2025 | Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136; | 198 units (25 US, 173 OUS) | Class II | Ongoing | 28 May 2025 |
| Z-1804-2025 | Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152; | 186 units (2 US, 184 OUS) | Class II | Ongoing | 28 May 2025 |
| Z-1805-2025 | Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153; | 72 units (6 US, 66 OUS) | Class II | Ongoing | 28 May 2025 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2025
- 945
- Share of these events in Class II
- 85%
- Product records in this event
- 18Median of the firm: 1
- Events of the firm on the register
- 129
Other events of the firm
Official channels
- FDA enforcement report Z-1788-2025The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 96889. https://recallregister.com/fda/ii/96889/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Côte D'Ivoire, Cyprus, Czech Republic, Denmark, Finland,…
- What quantity of product is in FDA event 96889?
- The event has 18 product records. The first record gives this quantity:
80 units (1 US, 79 OUS)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2025 have the same class?
- 85% of the 945 device events that started in 2025 are in Class II.