PICIS, CareSuite Family- OR Manager (4235), Preop Manager (4250), Anesthesia Manager (4220), PACU Manager (4245) & Criti
FDA device recall Z-0365-2010 · posted 2009-11-18 · Terminated
Recall details
- Recalling firm
- Picis Inc.
- 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.
- Action taken
- On 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- NSX
- Quantity affected
- 325
- Distribution
- Worldwide distribution: USA, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Italy, Malaysia, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, and United Kingdom
- Date initiated
- 2009-04-08
- Date posted
- 2009-11-18
- Date terminated
- 2014-12-22
- Location
- Wakefield, MA
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