Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and intervent
Summary
The FDA issued a Class II for Artis Q ceiling with software VD12-angiography systems developed for single and by Siemens Medical Solutions USA, Inc. Reason: If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ra.
Details
Source
Device Recall
External ID
Z-0301-2022
Action Date
2021-12-01
Status
Terminated
Category
device
Product Description
Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848281
Lot/Code Info: Serial Numbers: 110088 110059 110103 110035 110046 110005 110058 110056 110062 109523 109645 110067 110095 110051 110001 110020 110007 110093 110069 110075 109627 110042 110043 110048 110061 110063 110064 110032 110047 110102 110039 110040 110023 110065 110052 110018 110072 110081 110036 110054 110053 110044 110031 110016 110037 110077 109497 110079 110099 110027 110049 110066 110024 110017 110025 110100 110083 110091 110006 110055 110026 110022 110000 133501 110057 110104 110041 Expanded Recall 11/15/21: 110096 110014
Quantity Affected: 67 units
Reason for Recall
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
Distribution
US Nationwide Distribution
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-20
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-0301-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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