Device Recall Alaris PC Unit 8015 의 리콜

Recall

64653

Class 2

Z-1112-2013

2013-03-06

2013-04-15

Terminated

United States

2014-05-08

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116720

The recall was initiated because carefusion has identified potential risk associated with bolus programming with the alaris pc unit (model 8015) software version 9.12. automating infusion pump parameter input from either the electronic medical record (emr) or the alaris auto-id module for a continuous infusion with a bolus dose option may result in a loss of information from the guardrails data s.

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 actions 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. The letter stated that a Carefusion representatives will contact customers by telephone to schedule field remediation. For questions call Carefusion Support Center at 888-562-6018, Customer Advocacy at 888-812-3266, and/or Technical Support at 888-812-3229.