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Recall Observatory FDA recall evidence

Device 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.

Z-1814-2013

June 21, 2013

Class II

Product summary

Firm
Picis Inc.
Event
Event 65666
Status
Terminated
Classification
Class II
Quantity
35
Official record key
device-enforcement:Z-1814-2013

Official wording

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

Code information: Software Versions 5.2 and 5.3

Distribution pattern: Nationwide Distribution, including the states of: AK, AR, AZ, CA, CO, DC, DE, FL, GA, ID, IN, MA, MD, MO, NH, NJ, OH, OR, SC, TN, WA, and WV.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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