Z-1693-2023 Class II Ongoing
FDA device recall Z-1693-2023 was initiated by p-Chip Corporation on March 3, 2021 and is designated Class II. Reason for recall: The laser operation might fall under a higher laser class. The recall status is ongoing. Affected quantity: 329 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 21, 2023
- Initiation Date
- March 3, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 329 units
Product Description
p-Chip Wand Reader
Reason for Recall
The laser operation might fall under a higher laser class.
Distribution Pattern
US Nationwide Distribution
Code Information
Model: WA-4000, 4500, -8000, and -8500