McKesson Cardiology Hemo Software Recall for Hemoglobin Calculation Error
McKesson Information Solutions LLC is recalling 272 McKesson Cardiology Hemo devices because a software error incorrectly converts hemoglobin values used in formula calculations.
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 is classified as FDA Class II, and the hazard involves a software error in a medical device that could lead to inaccurate clinical data, representing a risk of harm where injury has not yet been reported.
Plain-English summary
McKesson Information Solutions LLC is recalling 272 McKesson Cardiology Hemo devices. These devices are intended for complete physiological and hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. The recall covers software versions 13.0, 13.0HF1, 13.0HF2, 13.0HF3, and 13.1.
The recall is due to a software error in the calculation section of the device. The error causes the device to incorrectly convert the Hemoglobin value before it is utilized in applicable formula calculations. This could result in inaccurate data processing and analytical assessment.
The devices were distributed worldwide, including nationwide in the United States and in Australia, Canada, Israel, and the United Kingdom. The FDA has classified this as a Class II recall. Users should contact McKesson Information Solutions LLC for further instructions on how to address the software error.
The recalled product
- Product
- McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
- Manufacturer
- Mckesson Information Solutions LLC
- Affected units
- 272
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 (5)
- McKesson CardiologyTM Hemo versions: 13.0
- 13.0HF1
- 13.0HF2
- 13.0HF3
- 13.1.
Distribution
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