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U.S. Department of Health and Human Services

Class 2 Device Recall PICIS

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 Class 2 Device Recall PICISsee related information
Date Initiated by FirmApril 08, 2009
Date PostedNovember 18, 2009
Recall Status1 Terminated 3 on December 22, 2014
Recall NumberZ-0365-2010
Recall Event ID 51876
Product Classification patient information systems - Product Code NSX
ProductPICIS, CareSuite Family- OR Manager (4235), Preop Manager (4250), Anesthesia Manager (4220), PACU Manager (4245) & Critical Care Manager (1110), patient information systems.
Code Information Software version 7.2.2
Recalling Firm/
Manufacturer		 Picis Inc.
100 Quannapowitt Parkway
Suite 405
Wakefield MA 01880
For Additional Information ContactSame as Above
781-557-3000
Manufacturer Reason
for Recall		Demographic data, most notably allergy and precaution data, can be overwritten with incomplete data or blanks by the interface between non-Picis clinical systems (your "HIS" or "CIS") and certain Picis applications, if that interface is not configured properly.
FDA Determined
Cause 2		Software design
ActionOn April 8th 2009, Picis initiated a customer notification letter to the installed base of potentially affected users, explaining the potential source of patient data conflict and to provide support in choosing the appropriate configuration option and implementation. The notification letters included with this report package contain additional details regarding configuration options.
Quantity in Commerce325
DistributionWorldwide distribution: USA, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Italy, Malaysia, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, and United Kingdom
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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