RegWardenFDA facility compliance records
Facility

SOTERA WIRELESS

1 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2013: 1 recalls; 2019: 1 inspections; 2024: 1 inspections1’13’14’15’16’17’181’19’20’21’22’231’24’25’26
  • Recalls (1)
  • Inspections (2)

Devices registered here (1)

  • Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
    Product code MHX (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1025

Recalls & enforcement

  • Class IITerminated2013-05-23
    Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor to cause a blister wound.

FDA inspections (2)

  • VAI2024-07-26
    Voluntary Action Indicated · Compliance: Devices · citations posted
  • VAI2019-03-06
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “SOTERA WIRELESS (FEI 3009673645) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009673645-sotera-wireless/

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