The Recall Desk

FDA (Devices) recall action 65718

Sotera Wireless, Inc. recalled 2 products on 2013-08-07

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2013-08-07
Critical
0
Units
165

Why these products were recalled

Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor to cause a blister wound.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2013-08-07

    Sotera Wireless Recalls ViSi Mobile Chest Sensors for Blister Risk

    Sotera Wireless is recalling 75 ViSi Mobile Chest Sensors because they may cause blister wounds on patients.

    Product
    ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2013-08-07

    Sotera Wireless Recalls ViSi Mobile Monitor Due to Blister Wound Risk

    Sotera Wireless is recalling 90 ViSi Mobile Monitoring Systems because the chest sensor may cause blister wounds.

    Product
    ViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.
    Category
    Distribution
    2 states