CLASS II ONGOING Device recall · Reported 14 Oct 2026 · FDA Enforcement Report
Nihon Kohden CNS-6200 Series Central Nurse Station recalled
Nihon Kohden America is recalling Nihon Kohden CNS-6200 Series Central Nurse Station, distributed nationwide in the US. The recall was initiated on 8 Sep 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0089-2027
- FDA event ID
- 99549
- Recalling firm
- Nihon Kohden America, Irvine, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Sep 2026
- FDA classified
- 6 Oct 2026
- Reported
- 14 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 8 Sep 2026 | Recall initiated by company | |
| 6 Oct 2026 | Classified by FDA | +28 days |
| 14 Oct 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds and the visualization of alarms.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software Version: software versions: 01-03, 01-04, 01-05, 01-06, 02-10, 02-11, and 02-40 Product Description: The device is intended for use by medical professionals to provide cardiac and vital signs monitoring for multiple patients within a medical facility. The CNS-6200 Series Central Nurse Station will display and record physiological data from up to forty telemetry receiver/transmitters and generates an alarm when a measured parameter falls outside a pre-set limit or when life threatening arrhythmia is detected. Arrhythmia detection and alarm determination are functions of the telemetry receivers/transmitters or individual bedside monitor. Component: No
Where it was distributed
US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN. KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NL, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, QA, WA, WI, WV and WY.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIllinoisIndianaKansasLouisianaMassachusettsMarylandMaineMichigan
Questions about this recall
Why was it recalled?
Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds and the visualization of alarms.
Which lots are affected?
Lot Code: CNS-6201 (PU-621RA), SW versions: 01-03, 01-04, 01-05, 01-06, 02-10, 02-11, and 02-40
Where was it sold?
US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN. KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NL, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, QA, WA, WI, WV and WY.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Nihon Kohden America
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|---|---|---|---|---|---|
| Device | CLASS II | Adult Cap-ONE Biteblock recalled by Nihon Kohden America | Nihon Kohden America | Other | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS III | Passport Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | T1 Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | cPM Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | BeneVision Series Telemetry Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | Panorama and Telemetry Monitoring System recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |