ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therap
Summary
The FDA issued a Class II for ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray phot by Siemens Medical Solutions USA, Inc. Reason: Potential safety issue under specific preconditons that may result in a user selecting the wrong site for treatment with the possibility to deliver do.
Details
Source
Device Recall
External ID
Z-0441-2022
Action Date
2022-01-05
Status
Terminated
Category
device
Product Description
ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Model Number: 8162815
Lot/Code Info: Serial Numbers: 10085 10524 10737 10736 10586 10792 10793 10822 10843 10850 10886 10865 11122 UDI: 040568691613655911
Quantity Affected: 13 units
Reason for Recall
Potential safety issue under specific preconditons that may result in a user selecting the wrong site for treatment with the possibility to deliver dose to the wrong isocenter which could result in serious patient injury
Distribution
US Nationwide distribution in the states of IA, LA, NE, NJ, NV, NY, OH, PA, SC, SD.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-09
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 90 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-0441-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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