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U.S. Department of Health and Human Services

Class 2 Device Recall CareSuite

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 Class 2 Recall
CareSuite
see related information
Date Posted April 06, 2010
Recall Status1 Terminated on July 01, 2013
Recall Number Z-1252-2010
Recall Event ID 54934
Product Classification Software, Transmission And Storage, Patient Data - Product Code NSX
Product CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager Software: CareSuite 5.1 and later
Code Information Software version CareSuite 5.1 and later.
Recalling Firm/
Manufacturer
Picis Inc.
100 Quannapowitt Parkway
Suite 405
Wakefield, Massachusetts 01880
For Additional Information Contact Karen A. Iorio
781-557-3000
Manufacturer Reason
for Recall
Under specific timing of conditions and in configuration with 3rd party infusion pumps, an error within the clinical application causes the manual documentation of clinical orders to be changed to an automatic update status. At this point, the order documentation becomes frozen at the last dose and/or rate and the user is unable to modify, stop or delete it. This error could impact the fluid bala
FDA Determined
Cause 2
DESIGN: Software Design
Action Picis issued letter notification beginning on March 8, 2010 with software correction information. The letter communicates details of the problem, along with recommendations for mitigating the potential to experience this error condition. Use of the product should be discontinued until the update described in the letter is performed. Customers with questions should call the company at 781-557-3000.
Quantity in Commerce 23
Distribution NJ Canada, Australia, Austria,Denmark, Finland, Germany Norway,Portugal, Sweden, France,Netherlands, Spain.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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