Recall Z-2132-2019 ยท MUE Full Field Digital, System, X-Ray, Mammographic
GE Healthcare, LLC
GE Pristina Serena - Product Usage: Pristina Serena is an optional accessory of Senographe Pristina intended to provide accurate location of lesions in the breast in three dimensions.
| Date | May 16, 2019 |
| Status | Terminated |
| Reason | Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure. |
| Root cause | Equipment maintenance |
| Action | On May 17, 2019, GE Healthcare sent letters to all of their consignees advising them of the recall, providing them with new instructions for use, and requesting that they complete the enclosed MEDICAL DEVICE NOTIFICATION ACKNOWLEDGEMENT RESPONSE REQUIRED forms. GE will follow-up and correct these systems, |
| Quantity | 16 |
| Distribution | Worldwide distribution - US nationwide distribution in the states of AZ, CA, FL, GA, IL, MI, MN, NC, NJ, NY, PA, TX, and VT, and countries of Algeria, Australia, Belgium, Canada, Chile, Columbia, Czech Republic, Finland, France, Germany, Hungary, Iceland, Japan, Korea (Republic of), Kuwait, Lebanon, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173576 | Pristina Serena GE Healthcare, May 14, 2018 |