Z-1508-2025Class II

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

Name: Z-1508-2025 Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
Creator: Pyrames Inc
Published: 2025-02-24
License: https://open.fda.gov/license/

Pyrames Inc / initiated 2025-02-24 / Open, Classified / root cause: software

FDA source

PYRAMES INC began a recall of Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007 on 2025-02-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1508-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-24
Posted: 2025-04-02
Recalling firm: Pyrames Inc
Product: Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
Product code: DXN System, Measurement, Blood-Pressure, Non-Invasive
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.
Root cause tag: software
FDA root cause: Software design
Action: The 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 [email protected] or 408-569-5215 for further information.
Quantity in commerce: 35
Distribution: US distribution to states of: MA and CA
Product codes and lots: Software version: 2.2.3 Part/UFI-DI/Lot: 54-0002/10860007282925/24020902, 24040302, 23103002; 51-0007/10860007282901/24011702, 24111301

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1508-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1508-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-04-02

Product code DXN

K223873Class IIBoppli Infant Blood Pressure MonitorPyrames, Inc. / cleared 2023-09-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)