FDA Recall Terminated

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.

Recall: Z-3160-2011 · Initiated August 1, 2011

Recall

Recall Number
Z-3160-2011
Event Number
59737
Firm
Picis Inc.
FEI Number
3005244943
Product Code
NSX
Status
Terminated
Root Cause
Software design
Initiated
August 1, 2011
Posted
September 7, 2011
Terminated
June 27, 2013
Address
100 Quannapowitt Parkway, Suite 405, Wakefield, MA, 01880

Description

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.

Reason

Software does not display appropriate allergy interaction warning

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.

Distribution

Nationwide Distribution

Quantity

62