SmartMonitor 2 PS/PSL — Class II medical device recall Z-2250-2017
Terminated recall by Circadiance LLC, reported 2017-06-14, distributed nationwide. Circadiance has determined that it is possible for certain Smart Monitor 2PS/PSL monitors to exhibit intermitt
| Recall number | Z-2250-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Circadiance LLC, Export, PA, United States |
| Recall initiated | 2017-05-01 |
| Classified | 2017-06-06 |
| Reported by FDA | 2017-06-14 |
| Terminated | 2018-02-05 |
| Distributed | Nationwide (US) |
| Quantity | 1,242 units |
| Model numbers | 1030271, 1038140, 1038141, U1030271, U1038140 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2250-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.