FDAFDA · Food and drugs·Recall number Z-0318-2017
Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract including the esophagus, stomach and duodenum.
Published November 2, 2016 · Recall initiated: August 15, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Pentax of America Inc
- Distributor
- US Nationwide and Japan
- Lot
- EG-1690K, EG-2490K, EG-279oI, EG-2790K, EG-2990K, EG-2990K, EG-349oK and EG-3890TK
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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