| Class 2 Device Recall WMTS Telemetry Receiver, Multiple Patient Receiver | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = DRG
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