Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable /… recallZ-1501-2015 · SenTec AG · initiated Mar 25, 2015

Why it was recalled

SenTec is voluntarily replacing V-Sign Sensors 2 due to pre-mature deterioration of a part of the PCO2 measuring unit and thus disabling PCO2-monitoring. This means that the affected sensors reach their end-of-life earlier than normally expected requiring the sensor`s replacement. There is no increased risk for the patient or operator, because the aforementioned deterioration results in the sens

FDA root cause category: Under Investigation by firm

What the company is doing

Sentec sent an Important Information letter via email dated March 25, 2015. The letter described the problem and the product involved in the recall. Customers were instructed to locate the affected sensors at their end-customers and replace them with the new sensors. Replaced sensors are to be returned to SenTec. For questions contact SenTec at + 41 61 726 97 60. Consignee was sent an emai in regard to the recall being expanded. The email was sent on May 08, 2014. The email informed the consignee of the additional lot being affected and provided a list of the serial number of V-Sign Sensors to be replaced.

Recall details

Recall number

Z-1501-2015

Recall class

Class II

Status

Terminated

Initiated by the company

Mar 25, 2015

Posted by the FDA

Apr 22, 2015

Recalling firm

SenTec AG

Quantity

129 US, 59 OUS

Product code

LKD

FDA submissions

K101690

Distribution

US Distribution to the state of : MO

Product description

Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, SenTec AG, CH-4106, Therwil, Switzerland. The SenTec Digital Monitoring System (SDMS) is used for continuous and non-invasive monitoring of transcutaneous carbon dioxide tension (tcPCO2), oxygen saturation (SpO2), and pulse rate (PR).

Other devices under the same FDA submission

6 devices cleared under K101690 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• Membrane Changer (reloadable) / single unit MC-R

  SenTec AG · Oximeter, Ear
  1 recall0 reports
• Membrane Changer Inserts MC-I

  SenTec AG · Oximeter, Ear
  1 recall0 reports
• V-Sign™ Sensor 2 VS-A/P/N

  SenTec AG · Oximeter, Ear
  1 recall0 reports
• Membrane Changer (single-use) / single unit MC

  SenTec AG · Oximeter, Ear
  1 recall0 reports
• Sentec Digital Monitor SDM

  SenTec AG · Oximeter, Ear
  1 report
• Multi-Site Attachment Ring for mature/intact skin MARe-MI

  SenTec AG · Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
  1 death1 report