Z-0093-2015Class II

McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic...

Name: Z-0093-2015 McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic...
Creator: Mckesson Information Solutions LLC
Published: 2014-06-25
License: https://open.fda.gov/license/

Mckesson Information Solutions, LLC / initiated 2014-06-25 / Terminated / root cause: labeling and UDI

FDA source

Mckesson Information Solutions LLC began a recall of McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and... on 2014-06-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0093-2015
Classification: Class II
Status: Terminated
Initiated: 2014-06-25
Posted: 2014-10-20
Terminated: 2017-10-26
Recalling firm: Mckesson Information Solutions, LLC
Product: McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
Product code: MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Reason for recall: 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 tag: labeling and UDI
FDA root cause: Labeling design
Action: Consignees were notified via Field Safety Notice on 06/25/2014.
Quantity in commerce: 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.
Product codes and lots: McKesson Cardiology TM Hemo versions: 11.0HF5, 11.1, 11.1SP5, 11.1SP6, 11.1SP6HF1, 11.1SP6HF3, 12SP1, 12.1, 12.1HF1, 12.1HF2, 12.2, 12.2HF1, 12.2HF2, 12.2HF3, 12.2HF4.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0093-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0093-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-29	2014-10-20

Product code MWI

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)