Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single
Summary
The FDA issued a Class II for Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf by Siemens Medical Solutions USA, Inc. Reason: Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table.
Details
Source
Device Recall
External ID
Z-0985-2022
Action Date
2022-04-27
Status
Ongoing
Category
device
Product Description
Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600
Lot/Code Info: S/N: 180062 180054 180019 180065 180056 180057 180041 180421 180317 180034 180072 180349 180367 180382 180060 180337 180070 180048 180083 180369 180370 180371 180372 180345 180315 180343 180080 180301 180305 180067 180330 180040 180379 180386 180360 180333 180029 180352 180336 180407 180412 180400 180397 180316 180068 180363 180084 180418 180334 180018 180350 180376 180354 180046 180047 180335 180085 180035 180339 180357 180358 180361 180362 180081 180423 180331 180411 180414 180381 180021 180342 180321 180309 180356 180378 180393 180368 180413 180341 180323 180329 180043 180049 180377 180077 180086 180053 180055 180015 180014 180066 180082 180037 180373 UDI: 04056869063317
Quantity Affected: 94 U.S.
Reason for Recall
Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors are related to the block movements function and manual rotation of the flat detector. Depending on the status of the intervention, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where clinical treatment may be delayed until an additional restart is performed
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-25
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 150 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-0985-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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