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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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Event Detail

Event ID 65666
Product Type Devices
Status Ongoing
Recalling Firm Picis Inc.
City Wakefield
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-21
Initial Firm Notification of
Consignee or Public
Letter
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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Software Versions 5.2 and 5.3 Class II Notes associated with prescription are not printed to the prescription or to the patient chart. 35 Z-1814-2013
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