Puritan Bennett recalls 980 ventilators with serial numbers 35B1300001-35B1801541 for potential GUI display errors from USB drive performance. Owners should check serial numbers and contact the company.
Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) functionality and labeling of the scalar waveform displayed on GUI during ventilation
Puritan Bennett is recalling its 980 ventilator series due to software issues with USB drives that could cause incorrect display of ventilator waveforms. This affects hospital use and patients needing respiratory support. The issue does not pose an immediate safety risk but requires attention to prevent misinterpretation of patient data.
The ventilator's software may display incorrect waveform patterns when using an external USB drive, which could lead to misinterpretation of patient breathing data. This is a technical issue with the GUI and does not cause physical harm but might affect clinical decisions.
Healthcare providers using Puritan Bennett 980 ventilators in hospitals or for patient transport are most at risk. Patients receiving ventilator support in neonatal, pediatric, or adult care could be affected if the display shows incorrect waveforms.
Check the serial numbers on your Puritan Bennett 980 ventilator, which range from 35B1300001 to 35B1801541. The product is used in hospitals for patients needing respiratory support from neonates to adults.
Identify your ventilator's serial number to confirm if it falls within the range 35B1300001 to 35B1801541.
The recall is for potential software issues with external USB drives that could cause incorrect display of waveform patterns on the ventilator's screen.
No, the recall does not require stopping use; it is a software update issue that does not pose an immediate safety risk.
Check the serial number on your ventilator; affected units have serial numbers between 35B1300001 and 35B1801541.
We’ve drafted a message you can send Puritan Bennett to request your refund or repair — edit it as you like.
Subject: Recall Z-0497-2019 — Puritan Bennett Puritan Bennett Hello, I own a Puritan Bennett that is covered by recall Z-0497-2019 from Puritan Bennett. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
