Recall Z-1294-2018
Seiler Instr. & Mfg. Co. Inc. · initiated January 1, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat.
Codes / lots: Model Number 6 ENT
Reason for recall
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.
FDA-determined cause: Use error
Action taken
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.
Details
- Recall number
- Z-1294-2018
- Initiated
- January 1, 2017
- Product code
- EPT – Microscope, Surgical
- 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.
- Recalling firm
- Seiler Instr. & Mfg. Co. Inc., Saint Louis, MO