Device Recall (1) Alaris Syringe module Model 8110 & Syringe Module 8120 의 리콜

Recall

47335

Class 2

Z-1712-2008

2008-03-05

2008-06-10

Terminated

United States

2011-09-13

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70264

A channel error on an affected alaris system module will stop an active infusion (or monitoring) with an audible and visual alarm. channel errors due to failure of the u9 socketed integrated circuits (u9 ic) on the display board of the alaris syringe module ("syringe module") and alaris pca module ("pca module") for modules manufactured on or before october 4, 2005. the user will be required to re.

An Urgent Medical Device Recall Notification letter was sent to consignees on April 10, 2008. Four customer letters were issued. The U19 IC issue affects only the Pump module and the U9 IC issue affects only the Syringe and PCA modules. Therefore there will be one letter for customers affected by all three issues Ul9 IC, U9 IC, and the IUI, one letter for affected Ul9 IC and U9 IC customers, one letter for U19 IC-only customers and one letter for U9 IC-only customers. All mailings were conducted through consignees (distributors as well as direct customers for the affected devices). Distributors will be sent multiple copies of the Recall Notification and Customer Response Cards. The Recall letters all includeRequired Actions sections which give their customers specific information about the issue and what the customers are to do and includes a web site link for each specific problem. Each recall letter also has chart of Cardinal Health contacts support.