Artis icono biplane with software VE20C-diagnostic recall: Software Issue
Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
Why was Artis icono biplane with software VE20C-diagnostic recalled?
Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be required during intervention; 3. Corrupted Image during Roadmap; 4. Unintended shutdown of Imaging System with UPS (Uninterruptable Power Supply) option
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers: 180062 180318 180054 180019 180065 180057 180041 180317 180034 180072 180349 180060 180337 180070 180048 180083 180369 180370 180345 180315 180343 180080 180301 180305 180067 180330 180040 180360 180333 180029 180352 180336 180316 180068 180363 180084 180334 180018 180350 180354 180046 180047 180335 180085 180035 180339 180357 180358 180361 180362 180081 180331 180021 180342 180321 180309 180356 180368 180341 180323 180329 180043 180049 180077 180086 180053 180055 180015 180014 180066 180082 180037 UDI: 04056869063317 Expanded Recall 12/20/21 S/N: 180056
- Product
- Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 72 units
- Distribution
- US Nationwide distribution.
- Recall date
- February 2, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)