Device Recall ActiveCare DVT 의 리콜

Recall

59812

Class 2

Z-0387-2012

2011-08-28

2012-01-11

Terminated

United States

2012-07-11

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103790

This voluntary field action is being undertaken because mcs has received a limited number of reports involving the use of a non-mcs ac/dc adaptor with the activecare dvt and activecare+s.F.T. devices. the firm found that an activecare dvt device may work improperly if connected to a non-mcs ac/dc adaptor with a higher nominal voltage. as specified in each product's user manual, the activecare dvt.

Medical Compression Systems (DBN) Ltd, sent out "VOLUNTARY FIELD ACTION" letters dated September 15, 2011 to all affected customers. The letter included description of the device and problem. Customers were instructed to check their inventory and make a list of serial numbers of all applicable ActiveCare+S.F.T. and ActiveCare DVT devices in their inventory, include the list on the attached excel file (Field Action Verification Form) and email to maya@mcsmed.com; even if they do not have any such devices. The letter also states that within 15 days from the email, they will receive instructions for the next steps. In addition, the letter stated -YOU MAY CONTINUE TO USE THE ActiveCare+S.F.T.¿ DEVICES WHILE AWAITINGTHE INSTALLATION OF THE OVP. In case you have questions or you need any assistance, you can contact the firm at (317) 485-7887 or e-mail to: maya@mcsmed.com or mahlet@mcsmed.com.