Recall Z-1549-2013 ยท IBM Microscope, Phase Contrast
Aperio Technologies Inc
Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. Automated digital slide creation and viewing device. It is intended to create and view electronic image files representative of tissue specimens fixed to glass slides.
| Date | Jun 17, 2013 (initiated Feb 22, 2013) |
| Status | Terminated |
| Reason | Aperio initiated this recall because the User Guides incorrectly state the devices had been cleared for specific applications. The User Guides should state the devices are for Research Use Only and are not for use in diagnostic procedures. |
| Root cause | No Marketing Application |
| Action | Aperio sent an Urgent Medical Device Recall letter dated April 22, 2013 to all affected consignees via certified USPS mail. The letter included the reason for the recall, recall product information, instructions, acknowledgement form, contact information ( Aperio Technical Support at 1-866-478-3999), and product labeling. The consignees were requested to acknowledge receipt of the Medical Device Correction letter. In addition, an Acknowledgement Form is required to be signed and e-mailed back to the Manufacturer as evidence of letter receipt. For questions regarding this recall call 760-304- |
| Quantity | 364 |
| Distribution | Nationwide Distribution - including all states, none internationally . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.