Device product
WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI
Z-1162-2021
Product summary
- 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
Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.