Picis ED Pulsecheck Software Recall for Missing Prescription Notes
Picis Inc. is recalling ED Pulsecheck software versions 5.2 and 5.3 because prescription notes are not printed to the prescription or patient chart.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a documentation error (missing printed notes) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Picis Inc. is recalling the Picis ED Pulsecheck EMR Software Application, versions 5.2 and 5.3. The recall involves 35 units distributed nationwide, including in Alaska, Arkansas, Arizona, California, Colorado, the District of Columbia, Delaware, Florida, Georgia, Idaho, Indiana, Massachusetts, Maryland, Missouri, New Hampshire, New Jersey, Ohio, Oregon, South Carolina, Tennessee, Washington, and West Virginia.
The recall was initiated because notes associated with prescriptions are not printed to the prescription or to the patient chart. This software application stores patient information in a database and analyzes or displays data for evaluation by healthcare professionals for informational purposes.
Healthcare facilities using these specific software versions should contact Picis Inc. for further instructions on how to address the issue.
The recalled product
- Product
- Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2 and 5.3. The application stores patient information in a database, and it may analyze and/or display the data in different formats for evaluation by healthcare professionals for informational…
- Manufacturer
- Picis Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 35
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 Versions 5.2 and 5.3
Distribution
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