Recall Z-0757-2017 ยท EOQ Bronchoscope (Flexible Or Rigid)
Pentax of America Inc
Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is in
| Date | May 31, 2016 |
| Status | Terminated |
| Reason | The EB-1970UK Ultrasound Video Bronchoscope shipped between the clearance date of April 2014 and September 2015 contained the Operation and Reprocessing IFUs that were in use prior to the 2014 clearance, and therefore did not include the cleared Operation and Reprocessing IFUs. |
| Root cause | Process control |
| Action | Pentax sent a US Urgent Field Correction letter to all affected customers with a field correction/field safety response form via USPS on May 31, 2016. The letter identified the product, the problem, and the action to be taken by the customer. Revised instructions were as follows: The instructions have been revised in the following manner: Operation IFU o Integrated all models of each family into the IFU o Modified the indications for use language to be consistent with similar products o Enhanced the explanation of the operation of the device o Revised and added cautions and warnings Repro |
| Quantity | 113 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131946 | ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS Pentax Medical Company, Apr 25, 2014 |