Z-1693-2023 Class II Ongoing

Recalled by p-Chip Corporation — Chicago, IL

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