Philips Medical Systems Nederland B.V.: Philips IntelliSpace Cardiovascular software, Model 830089.

Hazard

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

Details from the source

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. Quantity: 139 Lot/code info: Software version 7.0.0.0, UDI (01)00884838115378(11)221214(10)7.0.0.0.

UPC codes

00884838115378

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.