Class 2 Device Recall pChip Wand Reader

• Date Initiated by Firm: March 03, 2021
• Date Posted: June 12, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1693-2023
• Recall Event ID: 92483
• Product Classification: Fiber optic communication and data transfer - Product Code RFN
• Product: p-Chip Wand Reader
• Code Information: Model: WA-4000, 4500, -8000, and -8500
• Recalling Firm/ Manufacturer: p-Chip Corporation; 500 W Madison St; Suite 1000; Chicago IL 60661-4544
• For Additional Information Contact: Bill Eibon; 440-219-9168
• Manufacturer Reason for Recall: The laser operation might fall under a higher laser class.
• FDA Determined Cause: Radiation Control for Health and Safety Act
• Action: PCC will cover all shipping cost associated with the return of model WA-4000, WA 4500, WA-8000 and WA-8500 portable wand readers and replacement with the upgraded p-Chip WA 6000 portable wand reader. In lieu of an upgraded portable wand reader, customers can elect to receive a $150 Visa cash like gift card.
• Quantity in Commerce: 329 units
• Distribution: US Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.