Z-1264-2016Class II

Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device

Name: Z-1264-2016 Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device
Creator: Wfr/aquaplast Corp
Published: 2016-01-07
License: https://open.fda.gov/license/

Anholt Technologies Inc. / initiated 2016-01-07 / Terminated / root cause: manufacturing process

FDA source

Wfr/aquaplast Corp began a recall of Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device Product Usage: Clear Vue Prone Breast Treatment Table and Access ClearVision... on 2016-01-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1264-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-07
Posted: 2016-03-25
Terminated: 2017-01-06
Recalling firm: Anholt Technologies Inc.
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.
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Qfix sent a Field Safety Notification letter dated January 7, 2016 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached Inventory Survey form and mail it back. For questions call (610) 268-0585.
Quantity in commerce: 18 units of RT-4545CV-17 and 12 units of RT-4545CV-20
Distribution: Worldwide Distribution - US Nationwide in the states of NY, PA, CA, IL, and TX. Foreign Countries: Singapore, Australia, Saudi Arabia, and Spain.
Product codes and lots: device model numbers: RT-4545CV-17, RT-4545CV-20

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1264-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1264-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-28

Product code IYE

K090349Class IIClearvue Prone Breast Treatment TableOrbital Therapy, LLC / cleared 2009-03-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)