• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall ED PulseCheck

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
ED PulseCheck
see related information
Date Posted July 29, 2013
Recall Status1 Open
Recall Number Z-1814-2013
Recall Event ID 65666
Product Classification Software, Transmission And Storage, Patient Data - Product Code NSX
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.
Code Information Software Versions 5.2 and 5.3
Recalling Firm/
Manufacturer
Picis Inc.
100 Quannapowitt Parkway
Suite 405
Wakefield, Massachusetts 01880
For Additional Information Contact Support Representative
781-557-3000
Manufacturer Reason
for Recall
Notes associated with prescription are not printed to the prescription or to the patient chart.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
-
-