FDA recall Z-1252-2025

Philips Medical Systems Nederland B.V. · Class II · device

Product

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

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.

Key facts

Status: Ongoing
Initiation date: 2024-04-04
Report date: 2025-03-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Eindhoven, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1252-2025