Nihon Kohden NKV-550 Ventilator Recalled for Defective Pressure Regulator
Nihon Kohden NKV-550 Ventilators with certain serial numbers have a defective gas inlet pressure regulator that could cause malfunction or device check failure. The recall affects 1,999 units distributed globally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a critical life-support medical device with a defective pressure regulator that could affect proper device function. No injuries or hospitalizations have been reported, placing it in the High category as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric, and neonatal patients requiring invasive or noninvasive respiratory support. The recall affects units with a potential defect in the gas inlet pressure regulator.
The defective pressure regulator 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 prevent the device from passing checks prior to use.
The recall affects 1,999 units distributed worldwide, including to healthcare facilities in the United States and internationally. Affected units include those with serial numbers ranging from NKV5502019xxxx through NKV5502112xxxx, plus additional specific serial numbers identified in the recall notice.
The recalled product
- Product
- Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012 The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support.
- Manufacturer
- NIHON KOHDEN ORANGEMED, INC
- Category
- Medical Device — Ventilator
- Affected units
- 1,999
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- NKV55019370098R
- NKV55019430125R
- NKV55019470156R
- NKV55019470160
- NKV55020130200
- NKV55020140213R
- NKV55020140226R
- NKV55020140229
- NKV55020150241
- NKV55020150252
- NKV55020160268
- NKV55020160276
- NKV55020160277
- NKV55020160292R
- NKV55020160296
- NKV55020160297
- NKV55020160304
- NKV55020160307
- NKV55020160308
- NKV55020160310
Distribution
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