Recall Z-2968-2018 ยท DQK Computer, Diagnostic, Programmable
McKesson Israel Ltd.
McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. McKesson Cardiology Hemo is also intended for patient/procedural data management, such as documentation, log
| Date | Mar 12, 2018 |
| Status | Terminated |
| Reason | Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not display physiological signals. |
| Root cause | Software Design Change |
| Action | The firm, Change Healthcare Israel Ltd., sent an "Urgent Field Safety Notice" dated on 03/12/2018 to its customers. The notice explained the product, issue and actions to be taken. The customers were instructed to: distribute the notice to all those within your organization who need to be aware; alert other parties affiliated with your organization, which are affected by this field safety notice; and maintain awareness of this notice and resulting action until the defect has been corrected, to ensure effectiveness of the corrective action. Change Healthcare has developed software updates to a |
| Quantity | 31 units |
| Distribution | US Distribution to states of: CA, CO, CT, FL, GA, KS, IN, LA, NJ, NY, OK, OH, SC, and TX; and internationally to: UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131497 | MCKESSON CARDIOLOGY HEMO Mckesson Israel , Ltd., Dec 5, 2013 |