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U.S. Department of Health and Human Services

Class 2 Device Recall Picis ED PulseCheckSoftware

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  Class 2 Device Recall Picis ED PulseCheckSoftware see related information
Date Initiated by Firm August 01, 2011
Date Posted September 07, 2011
Recall Status1 Terminated 3 on June 27, 2013
Recall Number Z-3160-2011
Recall Event ID 59737
Product Classification Software, transmission and storage, patient data - Product Code NSX
Product Picis ED PulseCheck-Software, transmission & storage, patient data
Service Pack v5.0 L and M

This product is a non-alarming software patient information system that compiles an electronic medical record utilizing commonly available hardware. A patient record is populated with information from various sources, such as health care professionals, medical devices connected to the system, and data that arrives via hospital and laboratory information systems. The application stores this information in a database and displays it to healthcare providers in different formats for informational purposes. The product is intended for use by healthcare professionals.
Code Information Service Pack v5.0 L and M
Recalling Firm/
Manufacturer		 Picis Inc.
100 Quannapowitt Parkway
Suite 405
Wakefield MA 01880
For Additional Information Contact SAME
781-557-3000
Manufacturer Reason
for Recall		 Software does not display appropriate allergy interaction warning
FDA Determined
Cause 2		 Software design
Action Picis issued notification on 08/01/11 to affected clients, explaining the potential for the error, with instructions to monitor documented patient allergies closely when prescribing medication orders in ED PulseCheck, using Muitum drug database content. Picis will track the progress on acknowledgement of notification letter receipt through the implementation of software upgrade, for all potentially affected Customers. For questions regarding this recall call 781-557-3000.
Quantity in Commerce 62
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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