Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only.

FDA device recall Z-2076-2012 · posted 2012-07-26 · Terminated

Recall details

Recalling firm

CareFusion 303, Inc.

Reason for recall

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.

Action taken

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).

Root cause

Component design/selection

Status

Terminated

Product code

FRN

Quantity affected

112,912 units total (106,888 units in US)

Distribution

US Nationwide Distribution

Date initiated

2012-05-25

Date posted

2012-07-26

Date terminated

2014-05-13

Location

San Diego, CA

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