Recall Z-2132-2019
GE Healthcare, LLC · initiated May 16, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Serial# 738192BU4, 738574BU3, 734192BU8, 733706BU6, 718590BU3, 735558BU9, 738023BU1, 737211BU3, 739178BU2, 733600BU1, 738696BU4, 738793BU9, 738695BU6, 734169BU6, 733707BU4 and 732113BU6
Reason for recall
Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.
FDA-determined cause: Equipment maintenance
Action taken
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,
Details
- Recall number
- Z-2132-2019
- Initiated
- May 16, 2019
- Terminated
- December 16, 2020
- Product code
- MUE – Full Field Digital, System, X-Ray, Mammographic
- 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, New Zealand, Norway, Poland, Saudi Arabia, Senegal, South Africa, Sri Lanka, Sweden, Sweden…
- Recalling firm
- GE Healthcare, LLC, Waukesha, WI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2131-2019 Class II | GE Senographe Pristina - Product Usage: Senographe Pristina generates digital…Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure. | 05/16/2019Terminated |