Z-1162-2021 Class II Ongoing
FDA device recall Z-1162-2021 was initiated by Nihon Kohden America Inc on January 8, 2021 and is designated Class II. Reason for recall: Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter. The recall status is ongoing. Affected quantity: 4,436.
Recall Details
- Product Type
- Devices
- Report Date
- March 10, 2021
- Initiation Date
- January 8, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,436
Product Description
WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI
Reason for Recall
Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.
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.
Code Information
ORG 9100A serial numbers: 00001 to 01413 ORG 9110A serial numbers: 00001 to 02706 ORG 9700A serial numbers: 00001 to 00894