WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI
- Company
- Nihon Kohden America Inc
- Recall Initiated
- January 8, 2021
- Recall Number
- Z-1162-2021
- Quantity
- 4,436
- Firm Location
- Foothill Ranch, CA
Reason for Recall
Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.
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 / Code Info
ORG 9100A serial numbers: 00001 to 01413 ORG 9110A serial numbers: 00001 to 02706 ORG 9700A serial numbers: 00001 to 00894
Root Cause
Software design
Action Taken
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.