Uterine Electromyographic Monitor - Monica Novii recall
Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product Usage: The Novii Interface is an accessory to the Novii Pod which…
Why was Uterine Electromyographic Monitor - Monica Novii recalled?
if the cables of the Monica Novii System are removed by a user, and then incorrectly re-connected the Fetal Heart Rate (FHR) and Maternal Heart Rate (MHR) signals would be displayed incorrectly (swapped).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model # - 107-PT-020 ( all units distributed from January 2016- November 2017)
- Product
- Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product Usage: The Novii Interface is an accessory to the Novii Pod which…
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 1742
- Distribution
- Worldwide - US Nationwide Distribution.
- Recall date
- April 11, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)