Recall Z-0139-2012 ยท NSX
Picis Inc.
Picis Anesthesia Manager, PACU Manager,Critical Care Manager-8.2 Service Pack 4 or higher (Software, transmission & storage, patient data) This product is a non-alarming software patient information system that compiles an electronic medical record utilizing commonly available hardware. A patient record is populated with information from various sources, such as health care professionals, medica
| Date | Oct 31, 2011 (initiated Aug 12, 2011) |
| Status | Terminated |
| Reason | Periop/Critical Care Manager EHR Software Application displayed one patient's demographic and health information in place of another patient that was in current view. |
| Root cause | Software design |
| Action | Picis Inc. sent a "Safety Notification letter" dated August 12, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed until this service pack is applied, we recommend: * For patients who have been transferred from other facilities within the same VISN, you should discontinue the use of these Picis applications. Manually check the patient's name with that displayed in the Picis patient blue banner to ensure you catch all of these cases. * For all other patients, you may safely con |
| Quantity | 10 |
| Distribution | Nationwide Distribution -- AZ, DE, FL, IL, NY, OH, PA, WI and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.