Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1264-2016 — 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 support, is an accessory

U.S. FDA — Device Enforcement · United States · 2016-01-07 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1264-2016
Date of alert: 2016-01-07
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Wfr/aquaplast Corp
Product category: device
Product type: Devices

Reported risk: Some of the Access ClearVue Prone Breast devices may contain scales that are misaligned from the zero reference with respect to other Access ClearVue Prone Breast devices. This can result in differences in scale orientation.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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