Z-1252-2025 Class II Ongoing
FDA device recall Z-1252-2025 was initiated by Philips Medical Systems Nederland B.V. on Apr 4, 2024 and is designated Class II. Reason for recall: Study data is not able to be archived, copied, or exported with the cardiovascular software version. The recall status is ongoing. Affected quantity: 139.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 12, 2025
- Initiation Date
- Apr 4, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 139
Product Description
Philips IntelliSpace Cardiovascular software, Model 830089.
Reason for Recall
Study data is not able to be archived, copied, or exported with the cardiovascular software version.
Distribution Pattern
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.
Code Information
Software version 7.0.0.0, UDI (01)00884838115378(11)221214(10)7.0.0.0.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1252-2025
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026