SOMATOM Drive with software syngo.CT VB20 Model #10431700
Summary
The FDA issued a Class II for SOMATOM Drive with software syngo.CT VB20 Model #10431700 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-0287-2022
Action Date
2021-12-01
Status
Terminated
Category
device
Product Description
SOMATOM Drive with software syngo.CT VB20 Model #10431700
Lot/Code Info: Serial Numbers: 105081 105478 105152 105471 105315 105484 105182 105228 105207 105128 105123 105241 105105 105020 105063 105035 105022 105045 105052 105150 105485 105302 105472 105096 105477 105047 105023 105180 105115 105086 105295 105398 105051 105196 105445 105336 105383 105402 105202 105046 105109 105244 105498 105466 105461 105165 105060 105464 105103 105121 105141 105344 105066 105503 105118 105321 105184 105245 105339 105240 105507 105280 105440 105254 105403 105354 105427 105208 105012 105116 105363 105294 105080 105018 105237
Quantity Affected: 75 units
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-0287-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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