Z-1508-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 9, 2025
- Initiation Date
- February 24, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35
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.
Distribution Pattern
US distribution to states of: MA and CA
Code Information
Software version: 2.2.3 Part/UFI-DI/Lot: 54-0002/10860007282925/24020902, 24040302, 23103002; 51-0007/10860007282901/24011702, 24111301