Home / Recalls / Mckesson Information Solutions LLC / Z-0093-2015

Z-0093-2015 Class II Terminated

Recalled by Mckesson Information Solutions LLC — Alpharetta, GA

Recall Details

Product Type
Devices
Report Date
October 29, 2014
Initiation Date
June 25, 2014
Termination Date
October 26, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
625 devices

Product Description

McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.

Reason for Recall

McKesson Cardiology Hemo front-end parameter boxes must undergo annual maintenance testing to establish the proper functioning of the parameter boxes, and to identify in a timely manner whether a parameter box is out of calibration. McKesson has identified that its communication to customers regarding the required maintenance tests was insufficient. While each unit has an attached sticker i

Distribution Pattern

Worldwide Distribution-USA (nationwide) and the countries of Australia, Botswana, Canada, Germany, New Zealand, Netherlands, Pakistan, Portugal, South Africa, Turkey and The United Kingdom.

Code Information

McKesson Cardiology TM Hemo versions: 11.0HF5, 11.1, 11.1SP5, 11.1SP6, 11.1SP6HF1, 11.1SP6HF3, 12SP1, 12.1, 12.1HF1, 12.1HF2, 12.2, 12.2HF1, 12.2HF2, 12.2HF3, 12.2HF4.

Other recalls by Mckesson Information Solutions LLC

  • Z-0042-2015 Class II — McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monito (August 27, 2014)
  • Z-0976-2014 Class II — Horizon Medical Imaging, Picture Archive Communication System (PACS). (December 23, 2013)
  • Z-0556-2014 Class II — McKesson Radiology 12.0, Picture Archiving Communication System (PACSA). (October 15, 2013)
  • Z-2318-2013 Class II — McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, pro (September 4, 2013)