CIRCADIANCE
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
- Inspections (2)
Devices registered here (1)
- Ventilator, Non-Continuous (Respirator)Product code BZD (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5905
Recalls & enforcement
- Class IITerminated2017-05-01Circadiance has determined that it is possible for certain Smart Monitor 2PS/PSL monitors to exhibit intermittent operation of the nurse call feature. The firm has updated the device to increase the "Nurse Call" feature to ensure monitor alarms are transmitted to compatible nurs…
FDA inspections (2)
- NAI2019-03-20No Action Indicated · Compliance: Devices
- VAI2017-04-07Voluntary 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. “CIRCADIANCE (FEI 3006182632) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006182632-circadiance/
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