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Recall Observatory FDA recall evidence

Device product

WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI

Z-1162-2021

January 08, 2021

Class II

Product summary

Firm
Nihon Kohden America Inc
Event
Event 87264
Status
Ongoing
Classification
Class II
Quantity
4,436
Official record key
device-enforcement:Z-1162-2021

Official wording

Reason: Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.

Code information: ORG 9100A serial numbers: 00001 to 01413 ORG 9110A serial numbers: 00001 to 02706 ORG 9700A serial numbers: 00001 to 00894

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.