SIEMENS Biograph mCT: a) Flow 64-4R Seismic recall
SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R Seismic, f) S(20)-3R Mobile
Why was SIEMENS Biograph mCT: a) Flow 64-4R Seismic 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) Flow 64-4R Seismic, UDI/DI 405686900142560047, Material Number 10529161, Serial Number 60047; b) S(40)-3R Seismic, UDI/DI 405686900131960054, Material Number 10248668, Serial Number 60054; c) S(64)-3R Seismic, UDI/DI 405686900133360091, Material Number 10248669, Serial Number 60091; d) S(40)-4R Seismic, UDI/DI 405686900132660047, Material Number 10248671, Serial Number 60047; e) S(64)-4R Seismic, UDI/DI 405686900134060076, Material Number 10248672, Serial Number 60076; f) S(20)-3R Mobile, UDI/DI 405686900129660028, , Material Number 10534159, Serial Number 60028
- Product
- SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R Seismic, f) S(20)-3R Mobile
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Quantity
- 6 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)