SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603
Summary
The FDA issued a Class II for SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603 by Siemens Medical Solutions USA, Inc. Reason: software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interrupt.
Details
Source
Device Recall
External ID
Z-0286-2022
Action Date
2021-12-01
Status
Terminated
Category
device
Product Description
SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603
Lot/Code Info: Serial Numbers: 73917 73531 73126 98623 73066 74909 73152 73760 98602 98603 73476 73726 73586 73937 98616 74206 73544 73648 74156 73636 74207 73813 74360 73054 74128 73427 98600 73622 73621 73424 73423 73493 73520 73718 73296 73471 73786 74374 98620 73831 74042 74191 74405 74117 74118 73673 73497 74929 73409 73935 73642 74240 73657 73090 73030 73013 73300 73499 73535 73655 73355 73036 73908 74978 73008 74391 74209 73490 73059 73758 73513 98632 98630 74094 74098 73895 73141 74262 74158 74153 74192 73670 73051 73360 74226 74297 74234 74364 73162 73683 74068 73320 73635 73405 73547 73931 73135 73818 73873 73266 73197 74511 73591 98642 73905 73225 73938 98605 73443 74922 73886 73413 73445 74129 73261 74093 74251 73348 73430 73574 74152
Quantity Affected: 121 unit
Reason for Recall
software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-30
Company
Malvern, PA
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 132 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-0286-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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