McKesson Cardiology Hemo Software Recalled for Medication Data Discrepancies
Change Healthcare Israel Ltd. is recalling McKesson Cardiology Hemo software due to discrepancies in procedure medication data between system screens.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical software) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Change Healthcare Israel Ltd. is recalling 1,383 units of McKesson Cardiology Hemo software, version 13.x. The recall is due to a defect where users are not notified of procedure medication discrepancies between the Vitals and Meds, Procedure Notes, and Patient Common Data screens.
This discrepancy may also affect administered medication data in reports generated from Hemo or the Horizon/McKesson Cardiology Physician's Report. It may also impact customers who have implemented an outbound interface of procedure results.
The software was distributed nationwide to numerous U.S. states and internationally to Australia, Canada, Germany, Ireland, Israel, and the United Kingdom. Affected users should contact the recalling firm for further instructions.
The recalled product
- Product
- McKesson Cardiology Hemo
- Manufacturer
- Change Healthcare Israel Ltd.
- Category
- Medical Device — Software
- Affected units
- 1,383
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software version 13.x
Distribution
Part of a larger recall action
This product is one of 2 recalled by Change Healthcare Israel Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Change Healthcare Israel Ltd.
See all →- HighChange Healthcare Recalls Horizon Cardiology Hemo Software Due to Medication Discrepancies
FDA (Devices) · 2019-06-05
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