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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1814-2013 | Class II | Terminated | Voluntary: Firm initiated |
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