Aug

2013

Cl ll Picis ED Pulsecheck

Company:Picis Inc.
Date of Enforcement Report:8/7/2013
Class ll:

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 purposes. Recall Number Z-1814-2013

REASON
Notes associated with prescription are not printed to the prescription or to the patient chart.

RECALLING FIRM/MANUFACTURER
Picis Inc., Wakefield MA on 6/21/2013. Voluntary: Firm Initiated recall has is ongoing.

VOLUME OF PRODUCT IN COMMERCE
35

DISTRIBUTION
Nationwide

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl ll Picis ED Pulsecheck

Amy Sellers

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