Z-1162-2021Class II

WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/...

Name: Z-1162-2021 WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/...
Creator: Nihon Kohden America Inc
Published: 2021-01-08
License: https://open.fda.gov/license/

Nihon Kohden America Inc / initiated 2021-01-08 / Open, Classified / root cause: software

FDA source

Nihon Kohden America Inc began a recall of WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI on 2021-01-08. FDA classified it as Class II and gives the reason as "Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1162-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-01-08
Posted: 2021-03-02
Recalling firm: Nihon Kohden America Inc
Product: WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI
Product code: DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Reason for recall: Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.
Root cause tag: software
FDA root cause: Software design
Action: An URGENT RECALL NOTIFICATION was sent to the consignees via FedEx on 01/27/2021. Recall Instructions 1. Please notify all individuals that need to be made aware of this issue/recall, and that the recall notification should be posted with the affected products. 2. Complete the attached form and return to Nihon Kohden America. 3. If adverse reactions or quality problems are experienced with the use of this product, please report to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. " Online: www.f da.gov/medwatch/report.htm " Mail: Download form www.fda.gov/medwatch/getforms.htm or call 1-800-332-1088 to request a report form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. 4. If adverse reactions or quality problems are experienced with the use of this product, please report the event to Nihon Kohden Technical Support at: 1-800-325-0283 or email [email protected]. Issue Resolution Nihon Kohden America plans to release a new software version for the ORG-9100A / ORG 9110A. The ORG-9700A has the same issues but has been discontinued by the manufacturer and is no longer supported. Please contact your Nihon Kohden America Account Executive.
Quantity in commerce: 4,436
Distribution: 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.
Product codes and lots: ORG 9100A serial numbers: 00001 to 01413 ORG 9110A serial numbers: 00001 to 02706 ORG 9700A serial numbers: 00001 to 00894

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1162-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1162-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-10	2021-03-02

Product code DRG

K071058Class IIMultiple Patient Receiver, Model Org-9700ANihon Kohden America, Inc. / cleared 2007-06-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)