Z-2132-2019 Class II Terminated
FDA device recall Z-2132-2019 was initiated by GE Healthcare, LLC on May 16, 2019 and is designated Class II. Reason for recall: Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure. The recall status is terminated (terminated December 16, 2020). Affected quantity: 16.
Recall Details
- Product Type
- Devices
- Report Date
- August 7, 2019
- Initiation Date
- May 16, 2019
- Termination Date
- December 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16
Product Description
Reason for Recall
Distribution Pattern
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, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Vietnam.