Nihon Kohden recalls NKV-550 ventilators with specific serial numbers due to potential gas inlet pressure regulator defects that could cause alarms to fail or gas release noises.
Potential defective gas inlet pressure regulator within ventilator which could result in gas releasing noise from the bottom of the ventilator, a High Air/O2 Inlet Pressure alarm, a High/Low O2 alarm, or could not pass device Check prior to use.
Nihon Kohden is recalling NKV-550 ventilators with certain serial numbers because a defective gas inlet pressure regulator might cause alarms to fail or produce gas release noises. This could lead to unsafe oxygen levels for patients using the ventilator.
The ventilator's gas inlet pressure regulator may malfunction, causing alarms to fail or producing unusual gas release noises. This could lead to unsafe oxygen levels for patients who rely on the ventilator for respiratory support.
Healthcare providers and patients using the Nihon Kohden NKV-550 ventilator series are affected. Those with the specific serial numbers listed in the recall are most at risk.
Check the serial number on your ventilator. Affected units have serial numbers between NKV5502019xxxx and NKV5502112xxxx, plus specific listed serial numbers like NKV55019270055 or NKV55020130200.
Identify the serial number on your ventilator to see if it matches the affected range listed in the recall.
Reach out to Nihon Kohden for guidance on next steps if your ventilator is affected.
Ventilators with serial numbers between NKV5502019xxxx and NKV5502112xxxx, and specific listed serial numbers like NKV55019270055 or NKV55020130200.
The recall is due to a potential defect in the gas inlet pressure regulator that could cause alarms to fail or produce gas release noises, potentially leading to unsafe oxygen levels.
Check your serial number against the list provided in the recall. Contact Nihon Kohden for further instructions if your ventilator is affected.
We’ve drafted a message you can send Nihon Kohden to request your refund or repair — edit it as you like.
Subject: Recall Z-2435-2021 — Nihon Kohden Nihon Kohden Hello, I own a Nihon Kohden that is covered by recall Z-2435-2021 from Nihon Kohden. 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.
