Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/
Summary
The FDA issued a Class II for Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in c by Siemens Medical Solutions USA, Inc. Reason: Software error, the software can produce an incorrect interpretation of the table rotation if the table has been rotated by more than 4degrees in eith.
Details
Source
Device Recall
External ID
Z-0200-2022
Action Date
2021-11-10
Status
Ongoing
Category
device
Product Description
Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models: Product/Model #: syngo X Workplace, 10281061 syngo X Workplace, 10281299 syngo X Workplace, 10502522 Syngo Application Software, 10848815
Lot/Code Info: Artis zeego systems with Artis patient table and AppSW VD20C/VD20N
Quantity Affected: 43 US
Reason for Recall
Software error, the software can produce an incorrect interpretation of the table rotation if the table has been rotated by more than 4degrees in either direction. This can cause the 3D image reconstruction to be shown rotated by up to 5 degrees relative to the patient and to be used inappropriately by the system and result in incorrect treatment of the patient
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-24
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 120 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-0200-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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