FDA Medical Device Recalls (openFDA)
p-Chip Corporation: p-Chip Wand Reader
- Recall number
- Z-1693-2023
- Recalling firm
- p-Chip Corporation
- Product
- p-Chip Wand Reader
- Status
- Open, Classified
- Initiated
- 2021-03-03
- Posted
- 2023-06-12
- Terminated
- not on file
- Reason
- The laser operation might fall under a higher laser class.
- 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
- 329 units
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Model: WA-4000, 4500, -8000, and -8500
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- RFN
- Firm FEI
- 3027394592
- Firm city
- Chicago
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28