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U.S. Department of Health and Human Services

Class 2 Device Recall WMTS Telemetry Receiver, Multiple Patient Receiver

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  Class 2 Device Recall WMTS Telemetry Receiver, Multiple Patient Receiver see related information
Date Initiated by Firm January 08, 2021
Create Date March 02, 2021
Recall Status1 Open3, Classified
Recall Number Z-1162-2021
Recall Event ID 87264
510(K)Number K071058  
Product Classification Transmitters and receivers, physiological signal, radiofrequency - Product Code DRG
Product WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI:
ORG 9100A/ 00841983102554
ORG 9110A/ 00841983102561
ORG 9700A/No UDI
Code Information ORG 9100A serial numbers: 00001 to 01413 ORG 9110A serial numbers: 00001 to 02706  ORG 9700A serial numbers: 00001 to 00894
Recalling Firm/
Manufacturer		 Nihon Kohden America Inc
90 Icon
Foothill Ranch CA 92610-3000
For Additional Information Contact Nihon Kohden America Technical Services Group
949-580-1555
Manufacturer Reason
for Recall		 Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.
FDA Determined
Cause 2		 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 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DRG and Original Applicant = NIHON KOHDEN AMERICA, INC.
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