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
Summary
The FDA issued a Class II for SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R S by Siemens Medical Solutions USA, Inc.. Reason: This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position..
Details
Source
Device Recall
External ID
Z-1135-2023
Action Date
2023-02-22
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: 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
Quantity Affected: 6 units
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
Worldwide distribution - US Nationwide and the countries of Japan, Chile, Australia.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-01-16
Company
Hoffman Estates, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 157 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Siemens Medical Solutions USA, Inc. has 277 FDA actions in our database, including 173 recalls and 104 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siemens Medical Solutions USA, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Medical Solutions USA, Inc. have FDA actions?
Siemens Medical Solutions USA, Inc. has 277 FDA actions in our database, including 173 recalls and 104 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1135-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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