SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
Summary
The FDA issued a Class II for SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000 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-0289-2022
Action Date
2021-12-01
Status
Terminated
Category
device
Product Description
SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
Lot/Code Info: Serial Numbers: Serial Number 122022 122098 122062 122099 122121 122146 122054 122082 122080 122020 122164 122116 122008 122036 122029 122044 122172 122074 122075 122049 122141 122167 122156 122081 122126 122129 122090 122130 122089 122085 122037 122009 122163 122064 122038 122161 122168 122158 122144 122063 122086 122035 122041 122114 122107 122101 122108 122109 122162 122125 122011 122052 122034 122057 122145 122147 122106 122061 122051 122166 122170 122092 122004
Quantity Affected: 64 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-0289-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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