Device product

Philips IntelliSpace Cardiovascular software, Model 830089.

Z-1252-2025

April 04, 2024

Class II

Product summary

Firm: Philips Medical Systems Nederland B.V.
Event: Event 96129
Status: Ongoing
Classification: Class II
Quantity: 139
Official record key: device-enforcement:Z-1252-2025

Official wording

Reason: Study data is not able to be archived, copied, or exported with the cardiovascular software version.

Code information: Software version 7.0.0.0, UDI (01)00884838115378(11)221214(10)7.0.0.0.

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.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Study data is not able to be archived, copied, or exported with the cardiovascular software version.