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Recall Observatory FDA recall evidence

Device product

Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007

Z-1508-2025

February 24, 2025

Class II

Product summary

Firm
PYRAMES INC
Event
Event 96414
Status
Ongoing
Classification
Class II
Quantity
35
Official record key
device-enforcement:Z-1508-2025

Official wording

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.

Code information: Software version: 2.2.3 Part/UFI-DI/Lot: 54-0002/10860007282925/24020902, 24040302, 23103002; 51-0007/10860007282901/24011702, 24111301

Distribution pattern: US distribution to states of: MA and CA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.