ARTIS Pheno recall
ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Product Usage: Artis is a family of dedicated angiography systems developed for…
Why was ARTIS Pheno recalled?
Potential hardware issue which may cause thermal effects and possible damage to system parts.
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: 164033 164071 164034 164095 164057 164054 164055 164080 164072 164088 164048 164094 164068 164019 164013 164073 164025 164026 164027 164060 164083 164113 164021 164066 164075 164074 164084 164086 164098 164028 164053 164063 164064 164105 164024 164049 164018 164022 164061 164115 164100 164097 164011
- Product
- ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Product Usage: Artis is a family of dedicated angiography systems developed for…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 605 units in total
- Distribution
- US Nationwide Distribution
- Recall date
- August 22, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)