15
Apr
2010

Cl Il CareSuite Software

,
0

Company:Picis Inc
Date of Enforcement Report 4/15//2010
Class:ll

PRODUCT
CareSuite” – Critical Care Manager, PACU Manager and Anesthesia Manager Software. Recall # Z-1252-2010

REASON
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.

RECALLING FIRM/MANUFACTURER
Picis, Inc., Wakefield, MA, by letter beginning on March 8, 2010. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
29 units

DISTRIBUTION
NJ, Canada, Australia, Austria, Denmark, Finland, Germany Norway, Portugal, Sweden, France, Netherlands, Spain

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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