FDA Medical Device Recalls (openFDA)
Nihon Kohden America Inc: WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI
- Recall number
- Z-1162-2021
- 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
- Status
- Open, Classified
- Initiated
- 2021-01-08
- Posted
- not on file
- Terminated
- not on file
- Reason
- Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.
- 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 ORG@nihonkohden.com. 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
- 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.
- Lot, serial or model codes
- ORG 9100A serial numbers: 00001 to 01413 ORG 9110A serial numbers: 00001 to 02706 ORG 9700A serial numbers: 00001 to 00894
- 510(k) numbers
- ["K071058"]
- PMA numbers
- not on file
- Product code
- DRG
- Firm FEI
- 2080783
- Firm city
- Foothill Ranch
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28