SIEMENS Biograph Horizon 3R Mobile recall
SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission
Why was SIEMENS Biograph Horizon 3R Mobile recalled?
This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 405686901102894792, Material Number 10532746, Serial Number 94792
- Product
- SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Quantity
- 1 unit
- Distribution
- Worldwide distribution - US Nationwide and the countries of Japan, Chile, Australia.
- Recall date
- February 22, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)