Product Name: SmartPath to dStream for 3.0T; Model Number: 782145
Reported: May 28, 2025 Initiated: May 13, 2025 #Z-1789-2025
Product Description
Product Name: SmartPath to dStream for 3.0T; Model Number: 782145
Reason for Recall
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Details
- Recalling Firm
- Philips North America Llc
- Units Affected
- 12 units (OUS only)
- Distribution
- Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
Product Name: SmartPath to dStream for 3.0T; Model Number: 782145. Recalled by Philips North America Llc. Units affected: 12 units (OUS only).
Why was this product recalled? ▼
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 28, 2025. Severity: Moderate. Recall number: Z-1789-2025.
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