Recall Z-1508-2025— PYRAMES INC
Class II · Ongoing
Class II FDA medical device recall by PYRAMES INC, initiated 2025-02-24. It names one FDA 510(k) clearance: K223873. Product: Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007. 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..
- Recalling firm
- PYRAMES INC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-02-24
- Firm location
- Cupertino, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.