Z-1134-2023 Class II Ongoing
FDA device recall Z-1134-2023 was initiated by Siemens Medical Solutions USA, Inc. on January 16, 2023 and is designated Class II. Reason for recall: This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position. The recall status is ongoing. Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- February 22, 2023
- Initiation Date
- January 16, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission
Reason for Recall
This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Japan, Chile, Australia.
Code Information
UDI/DI 405686901102894792, Material Number 10532746, Serial Number 94792