Recall Z-1252-2010 ยท NSX
Picis Inc.
CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager Software: CareSuite 5.1 and later
| Date | Apr 6, 2010 (initiated Mar 8, 2010) |
| Status | Terminated |
| 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. 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 |
| Root cause | 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 | 23 |
| Distribution | NJ Canada, Australia, Austria,Denmark, Finland, Germany Norway,Portugal, Sweden, France,Netherlands, Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.