Boppli: Bedside Device Kit, REF: 54-0002 recallZ-1508-2025 · Pyrames Inc · initiated Feb 24, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Pyrames Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-1508-2025
- Status
- Open, Classified
- Initiated by the company
- Feb 24, 2025
- Posted by the FDA
- Apr 2, 2025
- Recalling firm
- Pyrames Inc
- Quantity
- 35
- Product code
- DXN
- FDA submissions
- K223873
- Distribution
- US distribution to states of: MA and CA
Product description
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
Code information (models, lots, serial numbers)
Software version: 2.2.3 Part/UFI-DI/Lot: 54-0002/10860007282925/24020902, 24040302, 23103002; 51-0007/10860007282901/24011702, 24111301
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Boppli 54-0002Pyrames Inc. · System, Measurement, Blood-Pressure, Non-Invasive1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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