Pentax Video Gastroscope is intended to be used with a recall
Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy…
Why was Pentax Video Gastroscope is intended to be used with a recalled?
PENTAX Medical is initiating this field action to provide customers that have purchased the affected endoscopes with the most recent Operation and Reprocessing IFUs.
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?
EG-1690K, EG-2490K, EG-279oI, EG-2790K, EG-2990K, EG-2990K, EG-349oK and EG-3890TK
- Product
- Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy…
- Recalling firm
- Pentax of America Inc
- Quantity
- 3,436 (US) and 14,488 (OUS)
- Distribution
- US Nationwide and Japan
- Recall date
- November 2, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)