Recall Z-0042-2015 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Mckesson Information Solutions LLC
McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
| Date | Oct 8, 2014 (initiated Aug 27, 2014) |
| Status | Terminated |
| Reason | Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula calculations. |
| Root cause | Software design (manufacturing process) |
| Action | On August 27, 2014, McKesson initiated a correction via a Field Safety Notice to all affected domestic customers. McKesson Israel will be responsible for contacting foreign consignees. |
| Quantity | 272 devices |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131497 | MCKESSON CARDIOLOGY HEMO Mckesson Israel , Ltd., Dec 5, 2013 |