Clear Vue Prone Breast Treatment Table and Access ClearVision Prone… — Class II medical device recall Z-1264-2016
Terminated recall by Wfr/aquaplast Corp, reported 2016-04-06, distributed nationwide. Some of the Access ClearVue Prone Breast devices may contain scales that are misaligned from the zero referenc
| Recall number | Z-1264-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Wfr/aquaplast Corp, Avondale, PA, United States |
| Recall initiated | 2016-01-07 |
| Classified | 2016-03-28 |
| Reported by FDA | 2016-04-06 |
| Terminated | 2017-01-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, ES, SA, SG |
| Model numbers | RT-4545CV-17, RT-4545CV-20 |
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 support, is an accessory for medical linear accelerator radiation therapy. It may be used with CT and MR scanners to acquire images for radiation therapy planning.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1264-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.