FDA Device recall Z-2250-2017
SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of…
- FDA Device
- Class II
- terminated
- Published 2017-06-14
On 2017-06-14 the FDA classified a Class II recall of SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of… by Circadiance, citing 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 dev….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2250-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-01 |
| Published | 2017-06-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Circadiance |
| Distribution | US |
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
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.
Identifiers
| code_info | Unique Device Identifier (UDI) 1030271, 1038140, 1038141, U1030271, and U1038140. All serial numbers of units with "…Unique Device Identifier (UDI) 1030271, 1038140, 1038141, U1030271, and U1038140. All serial numbers of units with "REF", "MODEL" or standalone part number 1030271, 1038140, 1038141, U1030271 or U1038140 located on the products label are impacted by this notice. Monitors with the above part numbers that have a serial number starting with "CP" are NOT affected by this issue. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2250-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.