FDA Recall Terminated

Picis Anesthesia Manager, PACU Manager,Critical Care Manager-8.2 Service Pack 4 or higher (Software, transmission & storage, patient data) 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-0139-2012 · Initiated August 12, 2011

Recall

Recall Number
Z-0139-2012
Event Number
60006
Firm
Picis Inc.
FEI Number
3005244943
Product Code
NSX
Status
Terminated
Root Cause
Software design
Initiated
August 12, 2011
Posted
October 31, 2011
Terminated
March 23, 2012
Address
100 Quannapowitt Parkway, Suite 405, Wakefield, MA, 01880

Description

Picis Anesthesia Manager, PACU Manager,Critical Care Manager-8.2 Service Pack 4 or higher (Software, transmission & storage, patient data) 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

Periop/Critical Care Manager EHR Software Application displayed one patient's demographic and health information in place of another patient that was in current view.

Action

Picis Inc. sent a "Safety Notification letter" dated August 12, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed until this service pack is applied, we recommend: * For patients who have been transferred from other facilities within the same VISN, you should discontinue the use of these Picis applications. Manually check the patient's name with that displayed in the Picis patient blue banner to ensure you catch all of these cases. * For all other patients, you may safely continue the use of these Picis applications. For further questions please call (781) 557-3000.

Distribution

Nationwide Distribution -- AZ, DE, FL, IL, NY, OH, PA, WI and WV.

Quantity

10