Z-1508-2025 Class II Ongoing
FDA device recall Z-1508-2025 was initiated by PYRAMES INC on Feb 24, 2025 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 35.
Recall details
- Product Type
- Devices
- Report Date
- Apr 9, 2025
- Initiation Date
- Feb 24, 2025
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1508-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026