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U.S. Department of Health and Human Services

Class 2 Device Recall SmartMonitor 2 PS/PSL

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 Class 2 Device Recall SmartMonitor 2 PS/PSLsee related information
Date Initiated by FirmMay 01, 2017
Create DateJune 06, 2017
Recall Status1 Terminated 3 on February 05, 2018
Recall NumberZ-2250-2017
Recall Event ID 77176
510(K)NumberK061256 
Product Classification Material, embolization, neurovascular, polymerizing or precipitating - Product Code NPE
ProductSmartMonitor 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.
Code Information 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.
Recalling Firm/
Manufacturer		 Circadiance LLC
1060 Corporate Ln
Export PA 15632-8905
For Additional Information Contact
724-858-2837
Manufacturer 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 Determined
Cause 2		Under Investigation by firm
ActionCircadiance 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 james.gianoutsos@circadiance.com. 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 Commerce1,242 units
DistributionNationwide Distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = NPE
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