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Terminated

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.

FDA Recall Z-1814-2013 · Posted 2013-07-29

Recalling FirmPicis Inc.
Recall StatusTerminated
Product CodeNSX
Date Initiated2013-06-21
Date Terminated2014-12-19
Product Quantity35

Reason for Recall

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

Firm Action

Initial customer notifications were sent via email on June 21, 2013 informing consignees of the recall and providing further instruction regarding the software solution. Consignees were provided with recommended actions until they receive the necessary update.

Root Cause

Software change control

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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