Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1693-2023Class II

p-Chip Wand Reader

p-Chip Corporation / initiated 2021-03-03 / Open, Classified

p-Chip Corporation began a recall of p-Chip Wand Reader on . FDA classified it as Class II and gives the reason as "The laser operation might fall under a higher laser class". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-1693-2023
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
p-Chip Corporation
Product
p-Chip Wand Reader
Product code
RFN Fiber Optic Communication And Data Transfer
Reason for recall
The laser operation might fall under a higher laser class.
FDA root 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
Product codes and lots
Model: WA-4000, 4500, -8000, and -8500

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1693-2023
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1693-2023Class IIOngoingFDA Mandated