Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
Recall
- Recall Number
- Z-1606-2016
- Event Number
- 73631
- Firm
- CareFusion 303, Inc.
- FEI Number
- 2016493
- Product Code
- FRN
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- March 24, 2016
- Terminated
- June 29, 2018
- Address
- 10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386
Description
Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
The Alaris PC units model 8015 may display a system error code 133.6080 due to failure with the super capacitor (C245) at power up on the Alaris PC unit logic boards.
The firm, Carefusion, sent a "Medical Device Recall Notification" letter dated March 30, 2016 to its customers. The letter described the product, problem, the potential risk involved and the required action for users. The customers were instructed to do the following: If you observe System Error code 133.6080, remove the PC unit from use and contact the CareFusion Support Center, and promptly complete and return the enclosed Customer Response Card. Customers with recall related questions are instructed to contact CareFusion Support Center at (888) 562-6018 from 7am-4pm PST, M-F, or by email at [email protected]. Customers with clinical inquiries, product complaints, or clinical troubleshooting are instructed to contact Customer Advocacy at (888) 812-3266, 24 hrs/day, 7 days/week or by email at [email protected]. Customers with technical questions regarding the Alaris System are instructed to contact Technical Support at (888) 812-3229, 6am-5pm PST, M-F or by email at [email protected].
Worldwide Distribution: US (nationwide) and countries of: Australia, Great Britain and Canada.
23,397 units