Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 19, 2017
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).
The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Nihon Kohden America Inc recalled Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affec… - a moderate-severity action.
Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affec… was recalled by Nihon Kohden America Inc in April 19, 2017. Reason: The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patien…. Check the official notice for the remedy. Verify recall #Z-1768-2017 with the FDA Devices before acting.
The recall
Nihon Kohden America Inc issued this moderate-severity FDA Devices recall-The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patien….
- Moderate
- severity level
- 654 units
- affected scope
- Class II
- classification
- April 19, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1768-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1768-2017) was formally reported on April 19, 2017, with the manufacturer initiating the action on March 13, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Nihon Kohden America Inc is listed as the recalling firm, operating out of Irvine, CA. Federal records list the affected scope as 654 units total (230 units in US).
The documented reason for this recall is: The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor. Distribution data in the federal record shows the product reached: Worldwide - US Nationwide Distribution including the countries of Germany, Spain, Brazil, Paraguay, Bolivia, Chile, Colombia, Costa Rica, Mexico, Peru, Pakistan, Israel, Qatar, Saudi Arabia, South Africa, Tunisia, Unite…. 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
654 units total (230 units in US)
Related Recalls
6
3 from same agency
Product description
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).
Reason for recall
The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1768-2017 |
| Date reported | April 19, 2017 |
| Date initiated | March 13, 2017 |
| Recalling firm | Nihon Kohden America Inc |
| Firm location | Irvine, CA |
| Affected scope | 654 units total (230 units in US) |
| Distribution | Worldwide - US Nationwide Distribution including the countries of Germany, Spain, Brazil, Paraguay, Bolivia, Chile, Colombia, Costa Rica, Mexico, Peru, Pakistan, Israel, Qatar, Saudi Arabia, South Africa, Tunisia, United Arab Emirates, Kor… |
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-1768-2017) 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? ▼
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).. Recalled by Nihon Kohden America Inc. Units affected: 654 units total (230 units in US).
Why was this product recalled? ▼
The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 19, 2017. Severity: Moderate. Recall number: Z-1768-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide - US Nationwide Distribution including the countries of Germany, Spain, Brazil, Paraguay, Bolivia, Chile, Colombia, Costa Rica, Mexico, Peru, Pakistan, Israel, Qatar, Saudi Arabia, South Africa, Tunisia, United Arab Emirates, Korea, Malaysia, Singapore, Thailand.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1768-2017) 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 April 19, 2017. 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.