Worldwide Distribtion-USA (nationwide) including Puerto Rico and the countries of Canada Greece Israel Belgium Finland France Germany Great Britain Ireland Italy Norway Poland Portugal Spain Sweden Switzerland Brazil Chile Philippines Taiwan Australia New Zealand.
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Philips HEARTSTART Multifunction Electrode Pads || Part Number: M3718A
“If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
Philips IntelliVue Patient Monitors ECG 12-lead option #C12(with the combination of s/w version (J.0, J.1, K.2, L.0) and ECG Firmware revision E.01.22)Affected Products:IntelliVue Multi Measurement ServerProduct Number: M3001AIntelliVue Multi Measurement Server SLCPProduct Number: M3001ALIntelliVue Multi Measurement Server X2Product Number: M3002AIntelliVue MP2Product Number: M8102AIntelliVue MP5Product Number: M8105AARTG Numbers: 118076 and 213953
Philips Network Firewall 867098 (Cisco ASA 5506 Firewall) used with the Philips IntelliVue Information Center iX or Classic Information CenterSerial Number: all numbers less than JMX2050000ARTG Number: 94237
Philips IntelliVue Information Center (PIIC) iXAll PIIC iX Surveillance stations including:866023 IntelliVue Info Center iX A.0866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0867141 IntelliVue Info Center iX B.0ARTG 94237