SOMATOM Edge Plus-Computed tomography system Model 1026700
Summary
The FDA issued a Class II for SOMATOM Edge Plus-Computed tomography system Model 1026700 by Siemens Medical Solutions USA, Inc. Reason: Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis..
Details
Source
Device Recall
External ID
Z-0474-2022
Action Date
2022-01-19
Status
Ongoing
Category
device
Product Description
SOMATOM Edge Plus-Computed tomography system Model 1026700
Lot/Code Info: Serial Numbers: 122022 122185 122098 122062 122099 122121 122146 122054 122082 122080 122020 122164 122116 122008 122036 122029 122044 122172 122074 122075 122049 122194 122141 122167 122156 122183 122081 122126 122129 122090 122130 122179 122089 122085 122037 122009 122163 122177 122066 122064 122038 122161 122132 122171 122153 122168 122158 122144 122063 122086 122035 122041 122112 122114 122107 122101 122108 122109 122162 122187 122174 122125 122178 122011 122182 122052 122034 122057 122145 122147 122050 122106 122189 122180 122061 122051 122166 122170 122092 122004 UDI: UDI 04056869006949
Quantity Affected: 80 units
Reason for Recall
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-19
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 106 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-0474-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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