Recall Z-1294-2018 ยท EPT Microscope, Surgical
Seiler Instr. & Mfg. Co. Inc.
Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat.
| Date | Jan 1, 2017 |
| Status | Open, Classified |
| Reason | The microscope may tip over if attachments are fully extended in one line and there is an attempt to move the device not by the handles mounted on the post. |
| Root cause | Use error |
| Action | The customer was notified via email on about January 4, 2017. Instructions included that the scope only tips if the user has it extended all the way out and is pulling on the handles of the scope. The end user must not pull on the handles of the scope when it is extended. They were also instructed to educate personnel on this matter. For further questions, please call (314) 968-2282. |
| Quantity | 43 units, but 1 affected |
| Distribution | Worldwide Distribution - US Distribution to the states of : CA, CO, FL, IL, MN, NV, OK, TX., and to the countries of : Canada, China, Ecuador, England, Greece, Guatemala, Jordan, Lebanon, Mexico, Romania, Russia, South Korea, Taiwan, Japan and United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.