Recall Z-1508-2025 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
PYRAMES INC
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
| Date | Apr 2, 2025 (initiated Feb 24, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| Action | 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 we |
| Quantity | 35 |
| Distribution | US distribution to states of: MA and CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223873 | Boppli Infant Blood Pressure Monitor Pyrames, Inc., Sep 29, 2023 |