PYRAMES recalls Boppli bedside blood pressure monitors for neonates due to vibratory noise causing inaccurate blood pressure readings. Affected units have specific model numbers and software versions. Contact PYRAMES for remedy.
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.
PYRAMES is recalling bedside blood pressure monitors for newborns because the device's vibratory noise can cause inaccurate blood pressure readings. This may lead to improper medical decisions if the device is used without proper calibration.
The monitor's vibratory noise can interfere with accurate blood pressure detection, potentially missing critical changes in a baby's blood pressure. This risk is highest when the device is used without proper positioning, such as when ventilator lines are near the monitor.
Parents and caregivers of neonates and infants using the Boppli blood pressure monitor. Infants in neonatal care facilities are most at risk due to the device's critical use in monitoring vital signs.
Check for model numbers 54-0002 (Bedside Device Kit) or 51-0007 (Sensor Band) with software version 2.2.3. Units were sold with specific production dates and batch numbers listed in the recall notice.
Place the monitor at least 12 inches from the infant's bed to avoid interference with ventilator lines or other equipment.
Verify the software version is 2.2.3 by checking the device's settings or documentation.
The Boppli monitor's vibratory noise can cause inaccurate blood pressure readings in neonates, potentially leading to improper medical decisions.
Check for model numbers 54-0002 (Bedside Device Kit) or 51-0007 (Sensor Band) with software version 2.2.3. Affected units have specific production dates and batch numbers listed in the recall notice.
Move the monitor to the infant's foot to avoid interference with ventilator lines. Ensure it is at least 12 inches away from the bed to prevent inaccurate readings.
We’ve drafted a message you can send PYRAMES to request your refund or repair — edit it as you like.
Subject: Recall Z-1508-2025 — PYRAMES PYRAMES Hello, I own a PYRAMES that is covered by recall Z-1508-2025 from PYRAMES. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
