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U.S. Department of Health and Human Services

Class 2 Device Recall Boppli

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 Class 2 Device Recall Bopplisee related information
Date Initiated by FirmFebruary 24, 2025
Date PostedApril 02, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1508-2025
Recall Event ID 96414
510(K)NumberK223873 
Product Classification System, measurement, blood-pressure, non-invasive - Product Code DXN
ProductBoppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
Code Information Software version: 2.2.3 Part/UFI-DI/Lot: 54-0002/10860007282925/24020902, 24040302, 23103002; 51-0007/10860007282901/24011702, 24111301
FEI Number 3014466900
Recalling Firm/
Manufacturer		 PYRAMES INC
21730 Stevns Crk Blvd Ste 201a
Cupertino CA 95014-1171
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionThe firm sent a MEDICAL DEVICE CORRECTIONS NOTTICE" dated 3/5/2025 to its customers describing the product, problem and actions to be taken. Starting on 2/24/2025, the firm started providing training to users to inform them of the following: Signal may be green, but high frequency noise appears superimposed on pulse waveform signal. Containment actions: 1) Ensure that ventilator lines do not physically touch the isolette (e.g. mattress, side rails, pillow) or baby. 2) Move Boppli to patient's foot. On 3/7/2025, correction notices were emailed to customers who in addition to the above were asked to do the following: 3) Use cuff measurement(s) to confirm that the signal is no longer affected by the high-frequency oscillatory ventilation (HFOV) interference. 4) Share this notice with anyone who needs to be made aware within the organization and forward to any organization where potentially affected devices have been transferred. 5) If these actions do not mitigate the issue, discontinue using the affected blood pressure monitoring device. Firm will be releasing a new version of software that will recognize the HFOV interference, indicate its presence by changing the signal color to red, and exclude that data from BP calculations. It is expected that this solution will be implemented by April 30, 2025. The Instructions for Use (55-0001 Rev. E) was updated to include warnings of vibratory interference, what it looks like and what to do when it is identified. Please contact support@pyrameshealth.com or 408-569-5215 for further information.
Quantity in Commerce35
DistributionUS distribution to states of: MA and CA
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DXN
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