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McKesson Cardiology Hemo recallZ-0093-2015 · Mckesson Information Solutions LLC · initiated Jun 25, 2014

Class II Terminated All recalls posted in October 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Mckesson Information Solutions LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Labeling design

What the company is doing

Consignees were notified via Field Safety Notice on 06/25/2014.

Recall details

Recall number
Z-0093-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Jun 25, 2014
Posted by the FDA
Oct 20, 2014
Recalling firm
Mckesson Information Solutions LLC
Quantity
625 devices
Product code
MWI
FDA submissions
K131497
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 description

McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.

Code information (models, lots, serial numbers)

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.

Other devices under the same FDA submission

9 devices cleared under K131497 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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