Recall Z-0365-2010 ยท NSX
Picis Inc.
PICIS, CareSuite Family- OR Manager (4235), Preop Manager (4250), Anesthesia Manager (4220), PACU Manager (4245) & Critical Care Manager (1110), patient information systems.
| Date | Nov 18, 2009 (initiated Apr 8, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 325 |
| Distribution | Worldwide distribution: USA, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Italy, Malaysia, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, and United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.