CareFusion Alaris PC Unit Model 8015 (formerly Medley PC Unit): Alaris PC Units (Model 8015) with logic board part numbe

FDA device recall Z-0006-2011 · posted 2010-10-13 · Terminated

Recall details

Recalling firm

CareFusion Corporation

Reason for recall

Under certain wireless network conditions a communication error can occur, which freezes the PC Unit screen, which may result in a delay of therapy. A delay of therapy may result in serious injury and/or death. CareFusion identified this potential risk associated with the Alaris PC unit model 8015 only (PC Unit) manufactured between December-2008 and September-2009.

Action taken

CareFusion sent the customer notification letter to all customers using the affected Alaris PC Unit beginning August 24, 2010. The customer notification letter is addressed to the Directors of Nursing, Risk Management, and Biomedical Engineering. Customers will be 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 recall notice informed the customers of the reason for the notice, the units affected, the potential risk, a step-by-step description of the issue and the required actions for users. The customers were also told that CareFusion will contact their facility through phone or in person within 60 days to initiate implementation of the corrective action. The corrective action will require a hardware update to all affected units. CareFusion does not require that you return your devices. In the interim, if you observe this issue, remove the device from service and contact CareFusion Recall Center immediately. Customers were also told that any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program. The recall notice provided contact information for CareFusion's Recall Center, Customer Advocacy and Technical Support units.

Root cause

Component design/selection

Status

Terminated

Product code

FRN

Quantity affected

17,081 units (17,050 in US)

Distribution

Nationwide and worldwide to: Canada, Netherlands, New Zealand and Singapore

Date initiated

2010-07-13

Date posted

2010-10-13

Date terminated

2011-12-12

Location

San Diego, CA

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