FDA Medical Device Recalls (openFDA)
McKesson Israel Ltd.: 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.
- Recall number
- Z-2968-2018
- Recalling firm
- McKesson 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.
- Status
- Terminated
- Initiated
- 2018-03-12
- Posted
- not on file
- Terminated
- 2021-11-23
- Reason
- Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not display physiological signals.
- 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
- 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.
- Lot, serial or model codes
- software versions: 13.0 HF1, 13.0HF2, 13.0HF3
- 510(k) numbers
- ["K131497"]
- PMA numbers
- not on file
- Product code
- DQK
- Firm FEI
- 3007784465
- Firm city
- Tel Aviv
- Firm state
- not on file
- Firm country
- Israel
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