Circadiance Recalls SmartMonitor 2 PS/PSL Apnea Monitors for Nurse Call Defect
Circadiance LLC is recalling 1,242 SmartMonitor 2 PS/PSL apnea monitors because the nurse call feature may operate intermittently, potentially preventing alarm transmission.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used for continuous patient monitoring where a failure to transmit alarms poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Circadiance LLC is recalling 1,242 units of the SmartMonitor 2 PS/PSL apnea monitors. These devices are intended for the continuous monitoring of respiration, heart rate, and SpO2 in infant, pediatric, and adult patients. The recall is due to a potential defect where the nurse call feature may exhibit intermittent operation, which could prevent monitor alarms from being transmitted to compatible nurse call systems.
The affected units are distributed nationwide and can be identified by the Unique Device Identifiers (UDI) 1030271, 1038140, 1038141, U1030271, and U1038140. Specifically, all serial numbers of units with these part numbers located on the product label are impacted. However, monitors with these part numbers that have a serial number starting with "CP" are not affected by this issue.
The firm has updated the device to increase the reliability of the "Nurse Call" feature to ensure that monitor alarms are properly transmitted. Users should check their device labels for the affected part numbers and serial number prefixes to determine if their unit is included in this recall.
The recalled product
- 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.
- Manufacturer
- Circadiance LLC
- Category
- Medical Device — Patient Monitor
- Affected units
- 1,242
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Unique Device Identifier (UDI) 1030271
- 1038140
- 1038141
- U1030271
- and U1038140. All serial numbers of units with "REF"
- "MODEL" or standalone part number 1030271
Distribution
Distributed nationwide across the United States.
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