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Recall Observatory FDA recall evidence

Device product

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.

Z-1131-2018

October 06, 2017

Class II

Product summary

Firm
CooperSurgical, Inc.
Event
Event 79213
Status
Terminated
Classification
Class II
Quantity
13 units
Official record key
device-enforcement:Z-1131-2018

Official wording

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

Code information: SIN 2017070001 SIN 2017070008 SIN 2017070002 SIN 2017070009 SIN 2017070003 SIN 2017070010 SIN 2017070004 SIN 2017070011 SIN 2017070005 SIN 2017070012 SIN 2017070006 SIN 2017070013 SIN 2017070007

Distribution pattern: Worldwide Distribution - US Nationwide and the countries of ( Canada and England)

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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