Z-1294-2018 Class II Ongoing
FDA device recall Z-1294-2018 was initiated by Seiler Instr. & Mfg. Co. Inc. on January 1, 2017 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 43 units, but 1 affected.
Recall Details
- Product Type
- Devices
- Report Date
- April 11, 2018
- Initiation Date
- January 1, 2017
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 43 units, but 1 affected
Product Description
Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat.
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.
Distribution Pattern
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.
Code Information
Model Number 6 ENT