Atlas FDA

Picis ED PulseCheck-Software, transmission & storage, patient data Service Pack v5.0 L and M This product is a non-alarm

FDA device recall Z-3160-2011 · posted 2011-09-07 · Terminated

Recall details

Recalling firm
Picis Inc.
Reason for recall
Software does not display appropriate allergy interaction warning
Action taken
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
Status
Terminated
Product code
NSX
Quantity affected
62
Distribution
Nationwide Distribution
Date initiated
2011-08-01
Date posted
2011-09-07
Date terminated
2013-06-27
Location
Wakefield, MA

Monitor recalls programmatically

Recalls and clearances share one API, with change alerts when new recalls post.