FHC Guideline 4000 5.0 GL5 Main Processing Unit recall
FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological activity, as well as aid in the…
Why was FHC Guideline 4000 5.0 GL5 Main Processing Unit recalled?
An electrical sub-circuit was not properly connected. Its purpose is to eliminate the possibility of interference with proper performance of the Guideline 5 Main Processing Unit, if an ESD event (greater than 6kV) were to occur.
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?
Serial Numbers: 45695, 48871, 48873, 48874, 46195, 46198
- Product
- FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological activity, as well as aid in the…
- Recalling firm
- FHC, Inc.
- Quantity
- 6 units
- Distribution
- US Nationwide distribution including in the states of CA, NC, TN, TX, WA.
- Recall date
- July 15, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)