Recall Z-1098-2013 ยท FRN Pump, Infusion
Carefusion Corporation
Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
| Date | Apr 15, 2013 (initiated Mar 6, 2013) |
| Status | Terminated |
| Reason | The recall was initiated because Carefusion has received reports of a communication error on the Alaris PC unit model 8015 with software version 9.12 when the Alaris EtCO2 module or Alaris SpO2 module is attached. |
| Root cause | Software design |
| Action | CareFusion sent an Urgent Medical Device Recall Notification letter dated March 6, 2013 to all affected customers. The letter identified the affected product, problem and action to be taken. Customers are required to confirm receipt of the notification by returning the Recall Response card to Carefusion by postage-paid, self-addressed mail, fax, or email. Carefusion representatives will contact customers by telephone to schedule field remediation. For questions contact CareFusion Support Center at 888-562-6018, Customer Advocacy at 888-812-3266 and/or Technical Support at 888-812-3229. |
| Quantity | 9,241 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Australia and China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051641 | ALARIS SYSTEM PC UNIT, MODEL 8001 Cardinal Health, Alaris Products, Oct 20, 2005 |