Recall Z-2968-2018— McKesson Israel Ltd.

Name: FDA recall Z-2968-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-12

Class II · Terminated

Class II FDA medical device recall by McKesson Israel Ltd., initiated 2018-03-12, terminated 2021-11-23. It names one FDA 510(k) clearance: K131497. Product: 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, logging, reporting, trending, storing, reviewing, carrying out clinical calculations and exporting various representations of the acquired data.. Reason: Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not display physiological signals..

Recalling firm: McKesson Israel Ltd.
Classification: Class II
Status: Terminated
Initiated: 2018-03-12
Terminated: 2021-11-23
Firm location: Tel Aviv, N/A, Israel

510(k) clearances named in this recall

1 on FDA's record

K131497 — MCKESSON CARDIOLOGY HEMOMckesson Israel , Ltd.·cleared 2013-12-05

K-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, 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, logging, reporting, trending, storing, reviewing, carrying out clinical calculations and exporting various representations of the acquired data.

Reason for recall

Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not display physiological signals.

Data sourced from openFDA. This site is unofficial and independent of the FDA.