PYRAMES INC: Device Recall
Recall #Z-1508-2025 · 02/24/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1508-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- PYRAMES INC
- Status
- Ongoing
- Date Initiated
- 02/24/2025
- Location
- Cupertino, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35
Reason for Recall
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.
Product Description
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
Distribution Pattern
US distribution to states of: MA and CA
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.