Nihon Kohden recalls PSG-1100 Sleep Diagnostic Systems with specific serial numbers due to electrical safety non-conformance with IEC 60601-1 standards. Affected units may pose a risk of electrical shock during sleep studies.
Medical device non-conformance to electrical safety standard (IEC 60601-1).
Nihon Kohden is recalling certain PSG-1100 Sleep Diagnostic Systems because they don't meet electrical safety standards. This could lead to electrical shock during sleep studies, which is a serious risk for users.
The device fails to meet electrical safety standards (IEC 60601-1), which could cause electrical shock during sleep studies. This is a serious hazard because medical devices must ensure user safety during diagnostic procedures.
People using the PSG-1100 Sleep Diagnostic System for sleep studies are affected. Those with specific serial numbers listed in the recall are most at risk.
Check the product label for serial numbers listed in the recall: 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, 1507-1516.
Look for the serial number on the product label to determine if it is affected.
The PSG-1100 Sleep Diagnostic System does not meet electrical safety standards (IEC 60601-1), which could cause electrical shock during sleep studies.
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, 1507-1516.
The recall record does not specify a remedy, so contact Nihon Kohden America Inc for further instructions.
We’ve drafted a message you can send Nihon Kohden to request your refund or repair — edit it as you like.
Subject: Recall Z-0865-2021 — Nihon Kohden Nihon Kohden Hello, I own a Nihon Kohden that is covered by recall Z-0865-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
