Philips North America: Device Recall
Recall #Z-1209-2026 · 12/03/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1209-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Philips North America
- Status
- Ongoing
- Date Initiated
- 12/03/2025
- Location
- Cambridge, MA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Reason for Recall
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Product Description
Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.
Other Recalls by Philips North America
- Class II: Risk 12/22/2025
- Class II: Risk 12/03/2025
- Class II: Risk 12/03/2025
- Class II: Risk 12/03/2025
- Class II: Risk 12/03/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.