Recall Z-1835-2013 ยท FRN Pump, Infusion
CareFusion 303, Inc.
Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules intended for use in todays growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices.
| Date | Aug 2, 2013 (initiated Jun 17, 2013) |
| Status | Terminated |
| Reason | CareFusion is recalling the Alaris PC units model 8015 (PC unit), version 9.12, because it is operating at an incorrect voltage and it could potentially experience a loss of communication between the PC Unit main Processor and Keyboard Processor. |
| Root cause | Process design |
| Action | The firm, Carefusion, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated June 17, 2013 to all customers who purchased the Alaris PC unit (model 8015) with version 9.12-Keyboard Processor. The recall letter informs the customers of the problems identified and the actions to be taken. The customers were instructed to either discontinue use of affect PC units until remediated or continue use on patients and follow the steps provided in the letter; fully charge Alaris PC units prior to use; during operation and when not in transport, keep Alaris PC units plugged in at all times; co |
| Quantity | 26,564 total units (26,220 units for US) |
| Distribution | Worldwide distribution: US (nationwide) and countries of: Australia, Canada and Europe. |
| 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 |