Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported February 3, 2021
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 (EEG) and other bio-potential signals and to record physiological data required for sleep studies.
Medical device non-conformance to electrical safety standard (IEC 60601-1).
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Nihon Kohden America Inc recalled PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS … - a moderate-severity action.
PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS … was recalled by Nihon Kohden America Inc in February 3, 2021. Reason: Medical device non-conformance to electrical safety standard (IEC 60601-1).. Check the official notice for the remedy. Verify recall #Z-0865-2021 with the FDA Devices before acting.
The recall
Nihon Kohden America Inc issued this moderate-severity FDA Devices recall-Medical device non-conformance to electrical safety standard (IEC 60601-1)..
- Moderate
- severity level
- 189 units
- affected scope
- Class II
- classification
- February 3, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0865-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0865-2021) was formally reported on February 3, 2021, with the manufacturer initiating the action on December 21, 2020. It is classified under Moderate severity (Class II), with a current status of Ongoing. Nihon Kohden America Inc is listed as the recalling firm, operating out of Foothill Ranch, CA. Federal records list the affected scope as 189 Units.
The documented reason for this recall is: Medical device non-conformance to electrical safety standard (IEC 60601-1). Distribution data in the federal record shows the product reached: US Nationwide Distribution - CA, CO, CT, FL, ID, IL, IN, MA, MD, MI, MO, NC, NM, NY, SC, TX, TN, UT, VA, VT and WA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
189 Units
Related Recalls
6
3 from same agency
Product description
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 (EEG) and other bio-potential signals and to record physiological data required for sleep studies.
Reason for recall
Medical device non-conformance to electrical safety standard (IEC 60601-1).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0865-2021 |
| Date reported | February 3, 2021 |
| Date initiated | December 21, 2020 |
| Recalling firm | Nihon Kohden America Inc |
| Firm location | Foothill Ranch, CA |
| Affected scope | 189 Units |
| Distribution | US Nationwide Distribution - CA, CO, CT, FL, ID, IL, IN, MA, MD, MI, MO, NC, NM, NY, SC, TX, TN, UT, VA, VT and WA. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0865-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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 (EEG) and other bio-potential signals and to record physiological data required for sleep studies.. Recalled by Nihon Kohden America Inc. Units affected: 189 Units.
Why was this product recalled? ▼
Medical device non-conformance to electrical safety standard (IEC 60601-1).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 3, 2021. Severity: Moderate. Recall number: Z-0865-2021.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution - CA, CO, CT, FL, ID, IL, IN, MA, MD, MI, MO, NC, NM, NY, SC, TX, TN, UT, VA, VT and WA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0865-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 3, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.