FDA Medical Device Recalls (openFDA)
Mckesson Information Solutions LLC: McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
- Recall number
- Z-0042-2015
- Recalling firm
- Mckesson Information Solutions LLC
- Product
- McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
- Status
- Terminated
- Initiated
- 2014-08-27
- Posted
- 2014-10-08
- Terminated
- 2016-05-18
- Reason
- Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula calculations.
- Root cause
- Software design (manufacturing process)
- Action
- On August 27, 2014, McKesson initiated a correction via a Field Safety Notice to all affected domestic customers. McKesson Israel will be responsible for contacting foreign consignees.
- Quantity
- 272 devices
- Distribution
- Worldwide distribution: US (nationwide) including states of: AR, CA, FL, DE, GA, HI, IL, IN, KS, LA, MA, MD, MN, MO, MS, MT, NJ, NV, OK, PA, SC, TNTX, , UT, WA; and countries of: Australia, Canada, Israel and the United Kingdom.
- Lot, serial or model codes
- McKesson CardiologyTM Hemo versions: 13.0, 13.0HF1, 13.0HF2, 13.0HF3, 13.1.
- 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