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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of physical injury (blister wounds) to patients, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported as a widespread or severe event.
Plain-English summary
Sotera Wireless, Inc. is recalling 75 units of the ViSi Mobile Chest Sensor (Catalog No. 93-10014) due to the potential for the device to cause a blister wound. 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.
The affected units were distributed in the United States, including California and Utah. The recall involves specific serial numbers listed in the agency's official records.
Clinicians and medically qualified personnel should stop using the affected sensors and contact Sotera Wireless for further instructions.
The recalled product
- 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.
- Manufacturer
- Sotera Wireless, Inc.
- Hazard
- Affected units
- 75
Distribution
Part of a larger recall action
This product is one of 2 recalled by Sotera Wireless, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Sotera Wireless, Inc.
See all →- HighSotera Wireless Recalls ViSi Mobile Monitor Due to Blister Wound Risk
FDA (Devices) · 2013-08-07
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