FDA recall Z-1162-2021

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2021-01-08

Report date

2021-03-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Foothill Ranch, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1162-2021