Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and inter
Summary
The FDA issued a Class II for Artis Q.zen ceiling with software VD12-angiography systems developed for single 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-0304-2022
Action Date
2021-12-01
Status
Terminated
Category
device
Product Description
Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848354
Lot/Code Info: Serial Numbers: Serial 111502 111503 111510 111507 111512 111508 111133 111504 111506 111513 111500 111501 111505 111514
Quantity Affected: 15 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-0304-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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