Recall Z-0093-2015 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Mckesson Information Solutions LLC
McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
| Date | Oct 20, 2014 (initiated Jun 25, 2014) |
| Status | Terminated |
| 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 |
| Root cause | Labeling design |
| Action | Consignees were notified via Field Safety Notice on 06/25/2014. |
| Quantity | 625 devices |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Australia, Botswana, Canada, Germany, New Zealand, Netherlands, Pakistan, Portugal, South Africa, Turkey and The United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131497 | MCKESSON CARDIOLOGY HEMO Mckesson Israel , Ltd., Dec 5, 2013 |