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U.S. Department of Health and Human Services

Class 2 Device Recall Picis Anesthesia Manager

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  Class 2 Device Recall Picis Anesthesia Manager see related information
Date Initiated by Firm August 12, 2011
Date Posted October 31, 2011
Recall Status1 Terminated 3 on March 23, 2012
Recall Number Z-0139-2012
Recall Event ID 60006
Product Classification Software, transmission and storage, patient data - Product Code NSX
Product 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.
Code Information 8.2 Service Pack 4 or higher.
Recalling Firm/
Manufacturer		 Picis Inc.
100 Quannapowitt Parkway
Suite 405
Wakefield MA 01880
For Additional Information Contact
781-557-3000
Manufacturer 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.
FDA Determined
Cause 2		 Software design
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.
Quantity in Commerce 10
Distribution Nationwide Distribution -- AZ, DE, FL, IL, NY, OH, PA, WI and WV.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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