ARTIS Pheno Interventional Fluoroscopic X-Ray System recall
ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
Why was ARTIS Pheno Interventional Fluoroscopic X-Ray System recalled?
Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while the unit is powered down for long periods (e.g. at night).
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?
164013 164011
- Product
- ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 429 total
- Distribution
- US nationwide distribution.
- Recall date
- September 26, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)