Class II — Circadiance LLC
| Recalling firm | Circadiance |
|---|---|
| Registered facility | CIRCADIANCE (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Circadiance 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 nurse call systems. |
| Product | SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients. |
| Quantity | 1,242 units |
| Distribution | Nationwide Distribution. |
| Initiated | 2017-05-01 |
| Classified | 2017-06-06 |
| Terminated | 2018-02-05 |
| Recall number | Z-2250-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Circadiance LLC (Z-2250-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77176/
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