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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
Plain-English summary
Sotera Wireless, Inc. is recalling 90 units of the ViSi Mobile Monitor, Catalog No. 92-10010. The device is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.
The recall was initiated due to the potential for the Chest Sensor to cause a blister wound. The affected units were distributed in the United States, including California and Utah.
Consumers and healthcare facilities should check their inventory for the specific serial numbers listed in the recall notice. If a unit is affected, it should be removed from service and returned to Sotera Wireless, Inc. for evaluation or replacement.
The recalled product
- 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.
- Manufacturer
- Sotera Wireless, Inc.
- Hazard
- Affected units
- 90
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 Chest Sensors for Blister Risk
FDA (Devices) · 2013-08-07
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