Picis Anesthesia Manager, PACU Manager,Critical Care Manager-8.2 Service Pack 4 or higher (Software, transmission & stor

FDA device recall Z-0139-2012 · posted 2011-10-31 · Terminated

Recall details

Recalling firm

Picis Inc.

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.

Action taken

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

Status

Terminated

Product code

NSX

Quantity affected

10

Distribution

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

Date initiated

2011-08-12

Date posted

2011-10-31

Date terminated

2012-03-23

Location

Wakefield, MA