Recall Z-0093-2015— Mckesson Information Solutions LLC
Class II · Terminated
Class II FDA medical device recall by Mckesson Information Solutions LLC, initiated 2014-06-25, terminated 2017-10-26. It names one FDA 510(k) clearance: K131497. Product: 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: 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.
- Recalling firm
- Mckesson Information Solutions LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-06-25
- Terminated
- 2017-10-26
- 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. 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.