CLASS II ONGOING Device recall · Reported 10 Mar 2021 · FDA Enforcement Report

WMTS Telemetry Receiver, Multiple Patient Receiver recalled

Nihon Kohden America is recalling WMTS Telemetry Receiver, Multiple Patient Receiver, distributed in 46 states. The recall was initiated on 8 Jan 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesORG 9100A serial numbers: 00001 to 01413 ORG 9110A serial numbers: 00001 to 02706 ORG 9700A serial numbers: 00001 to 00894

Quantity recalled4,436

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-1162-2021
FDA event ID: 87264
Recalling firm: Nihon Kohden America, Foothill Ranch, CA
Classification: Class II
Status: Ongoing
Recall initiated: 8 Jan 2021
FDA classified: 2 Mar 2021
Reported: 10 Mar 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

8 Jan 2021	Recall initiated by company
2 Mar 2021	Classified by FDA	+53 days
10 Mar 2021	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

Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.

Product as listed by the FDA

WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI

Where it was distributed

US - AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS,KY, LA, ME, MA, MD, MI, MS, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA WI, WV and WY.

Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland

Questions about this recall

Why was it recalled?

Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.

Which lots are affected?

ORG 9100A serial numbers: 00001 to 01413 ORG 9110A serial numbers: 00001 to 02706 ORG 9700A serial numbers: 00001 to 00894

Where was it sold?

US - AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS,KY, LA, ME, MA, MD, MI, MS, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, 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 26 Sep 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

All 11

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14 Oct 2026Device	CLASS II	Nihon Kohden CNS-6200 Series Central Nurse Station recalled	Nihon Kohden America	Device Malfunction	Nationwide
13 Nov 2024Device	CLASS II	Adult Cap-ONE Biteblock recalled by Nihon Kohden America	Nihon Kohden America	Other	Nationwide
6 Nov 2024Device	CLASS II	Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m recalled	Nihon Kohden America	Device Malfunction	29 states
6 Nov 2024Device	CLASS II	Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter recalled	Nihon Kohden America	Device Malfunction	29 states
12 Jun 2024Device	CLASS II	BSM-3000 Series Bedside Monitor recalled by Nihon Kohden America	Nihon Kohden America	Device Malfunction	Nationwide

Other Patient Monitors recalls

All 1,022

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS III	Passport Series Patient Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	T1 Patient Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	cPM Series Patient Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	BeneVision Series Telemetry Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	Panorama and Telemetry Monitoring System recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide