The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1264-2016·Announced 2016-04-06

Wfr/aquaplast Recalls Prone Breast Treatment Tables Due to Scale Misalignment

Wfr/aquaplast Corp is recalling 30 prone breast treatment tables and devices because some may have misaligned scales, potentially causing orientation differences.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a mechanical misalignment that could affect treatment planning but does not explicitly report injuries or hospitalizations, fitting the Moderate criteria for low-risk contamination or minor defects.

Plain-English summary

Wfr/aquaplast Corp is recalling 18 units of the Clear Vue Prone Breast Treatment Table (model RT-4545CV-17) and 12 units of the Access ClearVision Prone Breast Device (model RT-4545CV-20). These medical devices are used as patient supports for breast radiation therapy and may be used with CT and MR scanners for treatment planning.

The recall was initiated because some of the Access ClearVue Prone Breast devices may contain scales that are misaligned from the zero reference compared to other devices. This misalignment can result in differences in scale orientation.

The affected units were distributed worldwide, including nationwide in the United States (specifically New York, Pennsylvania, California, Illinois, and Texas) and in Singapore, Australia, Saudi Arabia, and Spain. No specific instructions for consumers are provided in the source text.

The recalled product

Product
Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device Product Usage: Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device is a medical charged-particle radiation therapy system. A breast radiation therapy patient…
Manufacturer
Wfr/aquaplast Corp
Category
Medical Device — Radiation Therapy Equipment
Hazard

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 (2)

  • device model numbers: RT-4545CV-17
  • RT-4545CV-20

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

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