Recall Z-0084-2014 ยท FCX Insufflator, Automatic Carbon-Dioxide For Endoscope
Pentax Medical Company
PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation.
| Date | Oct 28, 2013 (initiated Sep 16, 2013) |
| Status | Terminated |
| Reason | PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve. A manufacturing defect may cause improper stoppage of CO2 gas during an endoscopic procedure with the potential for serious hazard to and/or user. |
| Root cause | Use error |
| Action | PENTAX Medical sent an "Urgent Device Recall" notification letter with /Response forms dated September 16, 2013, via UPS Certified delivery to all affected customers. . The notification identified the affected product; informed the customers of the nature of the issue; advised of potential adverse patient consequences that may occur. The customer was asked to immediately examine their inventory and quarantine product subject to the recall. The customer was instructed to identify and notify their customers if they further distributed the product. The notification instructs users to return |
| Quantity | 76 units |
| Distribution | Nationwide Distribution including Arizona, California, Florida, Idaho, Indiana, Kansas, Maryland, Missouri, Missippi, North Carolina, New York, Pennsylvania, Virginia, Wisconsin and Wyoming. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K850020 | PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23 Pentax Precision Instrument Corp., Jul 9, 1985 |