FDA-Device2018-03-28Class II

Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB probe is for obstetrical use in the labor and department for late term obstetrical examination associated with larger women. The product detects fetal heart beats as an aid for determining fetal viability.

CooperSurgical, Inc.
Hazard

The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe

Sold states
Worldwide Distribution - US Nationwide and the countries of ( Canada and England)
Affected count
13 units
Manufactured in
95 Corporate Dr, N/A, Trumbull, CT, United States
Products
Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB probe is for obstetrical use in the labor and department for late term obstetrical examination associated with larger women. The product detects fetal heart beats as an aid for determining fetal viability.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1131-2018

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