Recall Z-0329-2014 ยท FEQ Pump, Air, Non-Manual, For Endoscope
Olympus America Inc.
Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tissues to remove blood, feces and other organic matter during endoscopic procedures.
| Date | Nov 15, 2013 (initiated May 20, 2013) |
| Status | Terminated |
| Reason | There is a possibility that the pump head was not shipped in the locked position. If the pump head is in an unlocked position this may, under certain circumstances, cause the pump to stop and go into power stand-by mode. |
| Root cause | Component design/selection |
| Action | Notification letters were sent to customers on May 20, 2013. |
| Quantity | 263 |
| Distribution | Worldwide distribution: USA (nationwide) and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100899 | OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 Keymed (Medical & Industrial Equipment), Ltd., Sep 13, 2010 |