The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1693-2023·Announced 2023-06-21

p-Chip Wand Reader Recalled for Laser Classification Safety Issue

FDA is recalling 329 p-Chip Wand Reader units due to laser operation potentially exceeding its classified safety level. Affected models are WA-4000, WA-4500, WA-8000, and WA-8500 distributed nationwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This Class II medical device recall involves a risk-of-harm hazard related to laser safety classification, where the device may operate at a higher laser class than declared. No illnesses or injuries have been reported, placing this at Score 3 per the rubric for risk-of-harm products without reported injury.

Plain-English summary

The FDA has issued a Class II recall for the p-Chip Wand Reader, a medical device manufactured by p-Chip Corporation. The recall affects 329 units with nationwide distribution. The device's laser operation may exceed the safety parameters of its current laser classification, presenting a potential safety hazard.

Affected models are WA-4000, WA-4500, WA-8000, and WA-8500. Healthcare facilities and users in possession of these devices should discontinue use.

Users and healthcare providers with questions about this recall or potential remediation options should contact p-Chip Corporation directly.

The recalled product

Product
p-Chip Wand Reader
Manufacturer
p-Chip Corporation
Category
Medical Device — Diagnostic Equipment / Laser Device
Hazard
Affected units
329

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Model: WA-4000
  • 4500
  • -8000
  • and -8500

Distribution

Distributed nationwide across the United States.

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