FDA Enforcement
Class II
Ongoing
Philips IntelliSpace Cardiovascular software, Model 830089.
Recall: Z-1252-2025
·
Reported March 12, 2025
Enforcement
- Recall Number
- Z-1252-2025
- Event ID
- 96129
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Philips Medical Systems Nederland B.V.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 12, 2025
- Initiation Date
- April 4, 2024
- Classification Date
- February 28, 2025
- Address
- High Tech Campus 36, Eindhoven, N/A, Netherlands
Description
Philips IntelliSpace Cardiovascular software, Model 830089.
Reason
Study data is not able to be archived, copied, or exported with the cardiovascular software version.
Code Info
Software version 7.0.0.0, UDI (01)00884838115378(11)221214(10)7.0.0.0.
Distribution
US Nationwide distribution in the states of AK, AL, AZ, CA, CT, FL, GA, IA, IN, KY, MA, MI, MN, NC, NE, NY, OH, OR, TN, TX, VA, and WI. There was government distribution but no military distribution.
Quantity
139