Recall Z-1883-2009 ยท BRY Cabinet, Table And Tray, Anesthesia
Cardinal Health Manufacturing LLC
Pyxis Anesthesia System 3500, Cardinal Health, Clinical Technologies and Services, San Diego, CA. The Pyxis Anesthesia Station 3500 is a medication dispensing product that provides medication and inventory management for the anesthesiologist at the point of care within the operating room. The system tracks and stores controlled substances, medications and supplies for anesthesia providers and aut
| Date | Sep 6, 2009 (initiated Dec 24, 2008) |
| Status | Terminated |
| Reason | Cardinal Health has sent out a Safety Alert Notification to inform its customers that the SR2b Software for the Pyxis Anesthesia System 3500 (PAS 3500) has received several customer reports of system "non-responsiveness" (lock ups) during the use of the product since its release in September 2008. |
| Root cause | Software design |
| Action | The "Safety Alert Notification" letter was mailed to all Pyxis Anesthesia System 3500 customers on December 17, 2008 by registered return receipt mail. The letter was addressed to the Director of Pharmacy at each facility. The mailing packages contain the "Safety Alert Notification" letter and the revised pages of the Pyxis Anesthesia System 3500 User Guide and Safety Manual. The "Safety Alert Notification" letter reinforced to customers how to maintain back-up processes to allow quick access if a system lock-up condition is experienced. The letter informed customers the situation will be cor |
| Quantity | 250 |
| Distribution | Nationwide and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.