Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device Product Usage: Clear Vue Prone Breast
FDA device recall Z-1264-2016 · posted 2016-03-25 · Terminated
Recall details
- Recalling firm
- Wfr/aquaplast Corp
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 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.
- Date initiated
- 2016-01-07
- Date posted
- 2016-03-25
- Date terminated
- 2017-01-06
- Location
- Avondale, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CLEARVUE PRONE BREAST TREATMENT TABLE (K090349) | Orbital Therapy, LLC | 2009-03-09 |