Z-2250-2017Class II

SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of...

Name: Z-2250-2017 SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of...
Creator: Circadiance LLC
Published: 2017-05-01
License: https://open.fda.gov/license/

Circadiance / initiated 2017-05-01 / Terminated

FDA source

Circadiance LLC began a recall of SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric... on 2017-05-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2250-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-01
Posted: 2017-06-06
Terminated: 2018-02-05
Recalling firm: Circadiance
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.
Product code: NPE Material, Embolization, Neurovascular, Polymerizing Or Precipitating
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.
FDA root cause: Under Investigation by firm
Action: Circadiance mailed a Medical Device Removal SmartMonitor 2 PS/PSL, dated 04/28/2017, to affected customers to inform them of the issue, the actions to be taken and the actions the firm plans to take to correct the issue. Customers are told to test the functionality of the system prior to each use; and, complete the Business Reply Form. The form can be returned via 412-202-4583 or emailed to [email protected]. Customers are to contact Circadiance Customer Service at 724-858-2837 to receive an Return Material Authorization number; or, 1-888-825-9640 to repair their unit free of charge, or for questions or support.
Quantity in commerce: 1,242 units
Distribution: Nationwide Distribution.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2250-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2250-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-06

Product code NPE

K061256Class IISmartmonitor 2PsRespironics, Inc. / cleared 2006-08-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)