SDMS (SenTec Digital Monitoring System)

FDA device recall Z-0088-2017 · posted 2016-10-17 · Terminated

Recall details

Recalling firm

SenTec AG

Reason for recall

Sentec AG found that with one batch of an internal SenTec Monitor component (Docking Station Module) there is a risk that a fastening screw could become loose under certain circumstances. A loose screw within the monitor can create uncontrolled electrical connections, including short circuits, with the risk of smolder or fire and electrical shock (patient and/or operator).

Action taken

Distributors were sent via e-mail a SenTec 'Mandatory initiated field correction action" letter dated September 15, 2016 . The letter provided a "Description of the issue, Affected products, Identify and localize affected products, Removal from use, Replacement of affected products at end customer & distributor / sub-distributor level". It also provided "action information for sub-distributors and affiliates, and end customers". For questions contact SenTec Inc. by e-mail (customersevice.usa@sentec.com) or phone (636-343-0000).

Root cause

Component change control

Status

Terminated

Product code

LKD

Quantity affected

75 (54 US; 21 =OUS)

Distribution

Worldwide Distribution - US Distribution to the states of : LA, MI, MO, OH, TN. and to the countries of : United Kingdom, The Netherlands and Australia.

Date initiated

2016-09-15

Date posted

2016-10-17

Date terminated

2017-06-23

Location

Therwil, Switzerland

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