ActiveCare DVT Medical Compression Systems OR Aqiva, IL Intended for use in: Preventing deep Vein Thrombosis; Enhancing

FDA device recall Z-0387-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Medical Compression Systems

Reason for recall

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

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

JOW

Quantity affected

2217 units

Distribution

Nationwide distribution.

Date initiated

2011-08-28

Date posted

2012-01-11

Date terminated

2012-07-11

Location

OR Aqiva, Israel

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