Recall Z-1162-2021 ยท DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Nihon Kohden America Inc
WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI
| Date | Jan 8, 2021 |
| Status | Open, Classified |
| 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071058 | MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A Nihon Kohden America, Inc., Jun 29, 2007 |