Recall Z-0042-2015— Mckesson Information Solutions LLC
Class II · Terminated
Class II FDA medical device recall by Mckesson Information Solutions LLC, initiated 2014-08-27, terminated 2016-05-18. It names one FDA 510(k) clearance: K131497. Product: McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.. Reason: Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula calculations..
- Recalling firm
- Mckesson Information Solutions LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-08-27
- Terminated
- 2016-05-18
- Firm location
- Alpharetta, GA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.