Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
Reported: April 9, 2025 Initiated: February 24, 2025 #Z-1508-2025
Product Description
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
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.
Details
- Recalling Firm
- PYRAMES INC
- Units Affected
- 35
- Distribution
- US distribution to states of: MA and CA
- Location
- Cupertino, CA
Frequently Asked Questions
What product was recalled? ▼
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007. Recalled by PYRAMES INC. Units affected: 35.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 9, 2025. Severity: Moderate. Recall number: Z-1508-2025.
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