Device Recall Alaris PC unit 의 리콜

Recall

62007

Class 1

Z-2076-2012

2012-05-25

2012-07-26

Terminated

United States

2014-05-13

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109684

The recall was initiated because the alaris pc unit model 8015 has a component on the pc unit power supply board that is causing an error code(120.4630) "system error" or "missing battery error" at start up. the error code is accompanied by both an audible alarm and visual error messages on the pc unit screen.

Carefusion sent an Urgent: Medical Device Recall Notification letter dated June 27, 2012 to all their customers who purchased the Alaris PC unit (model 8015). The letter identified the affected units, explanation of the problem, potential risk and actions to be taken. Customers were instructed to not return their devices. If customers observe either of the error messages identified in the letter, then they were instructed to remove the PC unit from use and contact the Carefusion Support Center. Carefusion will contact their facility by phone within 60 days of receiving this notification to schedule a visit to replace their affected power supply board on their PC unit. Customers were instructed to promptly complete and return the enclosed customer response card to expedite the corrective action process. For questions and support contact: CareFusion Support Center at 888-562-6018 for (Recall Related Questions), Customer Advocacy at 800-854-7128, Option 1, Option 1, Option 3 or email customerfeedback@carefusion.com for (Adverse Event Reports), Technical Support at 888-812-3229 for (Technical Questions Regarding the Alaris System).