Z-1814-2013 Class II Terminated
FDA device recall Z-1814-2013 was initiated by Picis Inc. on June 21, 2013 and is designated Class II. Reason for recall: Notes associated with prescription are not printed to the prescription or to the patient chart. The recall status is terminated (terminated December 19, 2014). Affected quantity: 35.
Recall Details
- Product Type
- Devices
- Report Date
- August 7, 2013
- Initiation Date
- June 21, 2013
- Termination Date
- December 19, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35
Product Description
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.
Reason for Recall
Notes associated with prescription are not printed to the prescription or to the patient chart.
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.
Code Information
Software Versions 5.2 and 5.3