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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.

FDA Recall Z-0139-2012 · Posted 2011-10-31

Recalling FirmPicis Inc.
Recall StatusTerminated
Product CodeNSX
Date Initiated2011-08-12
Date Terminated2012-03-23
Product Quantity10

Reason for Recall

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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