Nihon Kohden Bedside Monitor Recall for Pause Function Defect
Nihon Kohden America Inc is recalling 654 bedside monitors because the pause function on central monitors fails to automatically resume when connected to specific Life Scope G9 units.
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: The recall is classified as FDA Class II, and the hazard involves a functional defect in a medical device that could impact patient monitoring, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Nihon Kohden America Inc is recalling 654 units of the Bedside monitor CSM-1901 (Life Scope G9) with main unit CU-192RA. The recall affects 230 units in the United States and 424 units distributed worldwide in countries including Germany, Spain, Brazil, and others. The issue specifically involves the CSM-1901 (Life Scope G9) communicating with CNS-6201A (PU-621RA) or CNS-9701A (MU-971RA) central monitors.
The recall is due to a software defect where the Pause function on the central monitors will not automatically resume when connected to the affected Life Scope G9 patient monitors. This defect is limited to specific software versions: Life Scope G9 versions 01-19, 01-20, and 01-21 communicating with CNS-6201A versions 01-06, 02-10, or 02-40, or CNS-9701A version 01-89 or lower.
Healthcare facilities should identify affected units by checking the serial numbers and software versions listed in the recall notice. Users should contact Nihon Kohden America Inc for instructions on how to resolve the issue, which may involve software updates or other corrective actions.
The recalled product
- Product
- Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-6201A (PU-621RA) and CNS-9701A (MU-971RA).
- Manufacturer
- Nihon Kohden America Inc
- Category
- Medical Device — Patient Monitor
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 (5)
- 01-20
- and 01-21 communicating with CNS-6201A (PU-621RA) with version 01-06
- 02-10
- or 02-40 software. Life Scope G9 with version 01-19
- and 01-21 communicating with CNS-9701A (MU-971RA) with version 01-89 or lower.
Distribution
Distributed nationwide across the United States.
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