Z-2968-2018Class II

McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data...

Name: Z-2968-2018 McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data...
Creator: McKesson Israel Ltd.
Published: 2018-03-12
License: https://open.fda.gov/license/

Change Healthcare Israel Ltd. / initiated 2018-03-12 / Terminated / root cause: software

FDA source

McKesson Israel Ltd. began a recall of McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology Hemo is intended for... on 2018-03-12. FDA classified it as Class II and gives the reason as "Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not display physiological signals". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2968-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-12
Posted: 2018-08-31
Terminated: 2021-11-23
Recalling firm: Change Healthcare Israel Ltd.
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.
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not display physiological signals.
Root cause tag: software
FDA 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 address the problem. If you have any questions, contact Change Healthcare Customer Support (US) 1-800-654-4366 or (UK) 440(0) 208-952-799 to arrange for the installation of software update/upgrade.
Quantity in commerce: 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.
Product codes and lots: software versions: 13.0 HF1, 13.0HF2, 13.0HF3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2968-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2968-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-12	2018-08-31

Product code DQK

K131497Class IIMckesson Cardiology HemoMckesson Israel , Ltd. / cleared 2013-12-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)