FDA Medical Device Recalls (openFDA)
Mckesson Information Solutions LLC: McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
- Recall number
- Z-0093-2015
- 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.
- Status
- Terminated
- Initiated
- 2014-06-25
- Posted
- 2014-10-20
- Terminated
- 2017-10-26
- Reason
- 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
- Labeling design
- Action
- Consignees were notified via Field Safety Notice on 06/25/2014.
- Quantity
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K131497"]
- PMA numbers
- not on file
- Product code
- MWI
- Firm FEI
- 3002684279
- Firm city
- Alpharetta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28