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