Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1814-2013Class II

Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2 and 5.3. The application stores...

Picis Clinical Solutions, Inc. / initiated 2013-06-21 / Terminated / root cause: software

Picis Inc. began a recall of 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... on . FDA classified it as Class II and gives the reason as "Notes associated with prescription are not printed to the prescription or to the patient chart". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-1814-2013
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Picis Clinical Solutions, Inc.
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.
Product code
NSX
Reason for recall
Notes associated with prescription are not printed to the prescription or to the patient chart.
Root cause tag
software
FDA root cause
Software change control
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.
Quantity in commerce
35
Distribution
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.
Product codes and lots
Software Versions 5.2 and 5.3

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1814-2013
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1814-2013Class IITerminatedVoluntary: Firm initiated