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.
FDA Recall Z-3160-2011 · Posted 2011-09-07
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Recalling FirmPicis Inc.
Recall StatusTerminated
Product CodeNSX
Date Initiated2011-08-01
Date Terminated2013-06-27
Product Quantity62
Reason for Recall
Software does not display appropriate allergy interaction warning
Firm 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.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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