Z-0042-2015 Class II Terminated
FDA device recall Z-0042-2015 was initiated by Mckesson Information Solutions LLC on August 27, 2014 and is designated Class II. Reason for recall: Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula calculations. The recall status is terminated (terminated May 18, 2016). Affected quantity: 272 devices.
Recall Details
- Product Type
- Devices
- Report Date
- October 15, 2014
- Initiation Date
- August 27, 2014
- Termination Date
- May 18, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 272 devices
Product Description
McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
Reason for Recall
Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula calculations.
Distribution Pattern
Worldwide distribution: US (nationwide) including states of: AR, CA, FL, DE, GA, HI, IL, IN, KS, LA, MA, MD, MN, MO, MS, MT, NJ, NV, OK, PA, SC, TNTX, , UT, WA; and countries of: Australia, Canada, Israel and the United Kingdom.
Code Information
McKesson CardiologyTM Hemo versions: 13.0, 13.0HF1, 13.0HF2, 13.0HF3, 13.1.