FDA Medical Device Recalls (openFDA)
Circadiance LLC: 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.
- Recall number
- Z-2250-2017
- Recalling firm
- Circadiance LLC
- 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.
- Status
- Terminated
- Initiated
- 2017-05-01
- Posted
- not on file
- Terminated
- 2018-02-05
- 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.
- 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 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
- 1,242 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K061256"]
- PMA numbers
- not on file
- Product code
- NPE
- Firm FEI
- 3006182632
- Firm city
- Export
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28