PYRAMES INC recalls Boppli: Bedside Device Kit

Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibratory noise, may not adequately detect changes in blood pressure per specification. Containment actions: 1) Ventilator lines not to touch the isolette (e.g. mattress, side rails, pillow) or patient, 2) Move affected monitor to patient's foot.

The firm sent a MEDICAL DEVICE CORRECTIONS NOTTICE" dated 3/5/2025 to its customers describing the product, problem and actions to be taken. Starting on 2/24/2025, the firm started providing training to users to inform them of the following: Signal may be green, but high frequency noise appears superimposed on pulse waveform signal. Containment actions: 1) Ensure that ventilator lines do not physically touch the isolette (e.g. mattress, side rails, pillow) or baby. 2) Move Boppli to patient's foot. On 3/7/2025, correction notices were emailed to customers who in addition to the above were asked to do the following: 3) Use cuff measurement(s) to confirm that the signal is no longer affected by the high-frequency oscillatory ventilation (HFOV) interference. 4) Share this notice with anyone who needs to be made aware within the organization and forward to any organization where potentially affected devices have been transferred. 5) If these actions do not mitigate the issue, discontinue using the affected blood pressure monitoring device. Firm will be releasing a new version of software that will recognize the HFOV interference, indicate its presence by changing the signal color to red, and exclude that data from BP calculations. It is expected that this solution will be implemented by April 30, 2025. The Instructions for Use (55-0001 Rev. E) was updated to include warnings of vibratory interference, what it looks like and what to do when it is identified. Please contact support@pyrameshealth.com or 408-569-5215 for further information.

• FDA enforcement recordOfficial FDA database entry for Z-1508-2025
• FDA 510(k) clearance · K223873The device's official FDA premarket clearance record
• FDA device classification · DXNOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.1130The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find PYRAMES INCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.