Nihon Kohden PSG-1100 Sleep Diagnostic System Recalled for Electrical Safety Non-Conformance
Nihon Kohden America Inc is recalling 189 PSG-1100 Sleep Diagnostic Systems because they do not meet the IEC 60601-1 electrical safety standard.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, and the hazard is a standard non-conformance without explicit reports of significant harm, fitting the Moderate criteria for low-risk or precautionary issues.
Plain-English summary
Nihon Kohden America Inc is recalling 189 units of the PSG-1100 Sleep Diagnostic System. This digital PSG amplifier is intended to record the electrical activity of the brain (EEG) and other bio-potential signals required for sleep studies. The recall is due to a non-conformance with the IEC 60601-1 electrical safety standard.
The affected units were distributed nationwide in the United States, specifically in California, Colorado, Connecticut, Florida, Idaho, Illinois, Indiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Mexico, New York, South Carolina, Texas, Tennessee, Utah, Virginia, Vermont, and Washington. The recall covers specific serial numbers ranging from 320 to 1516, including various ranges such as 1165-1183 and 1214-1293.
The source text does not specify the actions consumers or healthcare facilities should take, nor does it report any injuries or illnesses associated with this recall. The hazard is identified strictly as a failure to meet the specified electrical safety standard.
The recalled product
- Product
- PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI (01) 04931921108383; Made in Japan The PSG-1100 Sleep Diagnostic System is a digital PSG amplifier intended to record the electrical activity of the brain
- Manufacturer
- Nihon Kohden America Inc
- Hazard
- Affected units
- 189
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)
- Serial numbers 3. Serial numbers 320
- 470
- 507
- 534
- 621
- 757
- 770
- 795
- 892
- 1165-1183
- 1186- 1205
- 1214-1293
- 1295-1297
- 1304-1330
- 1333-1342
- 1358 -1384
- 1387-1389
- 1391-1413
- 1421-1430
- 1434-1505
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