Boppli Bedside Device Kit blood pressure monitor may fail to detect pressure changes
Boppli bedside blood pressure monitors for infants may not adequately detect blood pressure changes due to vibratory noise. Affected monitors should be moved to patient's foot and ventilator lines kept away from the isolette.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a monitoring device for a high-risk population (neonates/infants) where the device may fail to detect clinically important changes. No hospitalizations or injuries have been reported; the hazard is potential rather than realized.
Plain-English summary
PYRAMES INC is recalling the Boppli Bedside Device Kit (REF: 54-0002) and Sensor Band (REF: 51-0007), single-use battery-powered blood pressure monitors designed for use on neonates and infants.
The devices may not adequately detect changes in blood pressure due to vibratory noise.
Thirty-five units have been distributed in Massachusetts and California. The affected software version is 2.2.3.
Containment actions include: ventilator lines must not touch the isolette (including mattress, side rails, and pillow) or patient, and the affected monitor should be moved to the patient's foot.
The recalled product
- Product
- Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
- Manufacturer
- PYRAMES INC
- Hazard
- Affected units
- 35
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Software version: 2.2.3 Part/UFI-DI/Lot: 54-0002/10860007282925/24020902
- 24040302
- 23103002
- 51-0007/10860007282901/24011702
- 24111301
Distribution
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