SIEMENS Biograph Vision: a) 450 recall
SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge
Why was SIEMENS Biograph Vision: a) 450 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?
a) 450: UDI/DI 405686923807410106, Material Number 10749669, Serial Number 10106; b) 600: UDI/DI 405686922450311120, Material Number 10749670, Serial Number 11120; UDI/DI 405686922450311116, Material Number 10749670, Serial Number 11116; c) 600 Edge: UDI/DI 405686918321311068, Material Number 10749672, Serial Number 11068
- Product
- SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Quantity
- 4 units
- 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)