AXIOM Artis dBA recall
AXIOM Artis dBA, Model Number 7555357
Why was AXIOM Artis dBA recalled?
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
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: 53181 53023 53167 53104 53067 53093 53162 53706 53058 53098 53253 53016 53188 53209 53223 53700 53017 53114 53063 53219 53033 53142 53116 53002 53086 53195 53165 53076 53064 53124 53176 53078 53111 53227 53202 53133 53140 53047 53710 53190 53180 53128 53185 53170 53187 53019 53141 53084 53074 53225 53215 53189 53056 53166 53149 53020 53096 53009 53147 53070 53049 53261 53122 53065 53031 53085 53026 53222 53090 53075 53256 53045 53057 53103 53182 53012 53022 53175 53194 53102 53109 53260 53043 53160 53117
- Product
- AXIOM Artis dBA, Model Number 7555357
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 85
- Distribution
- US Nationwide Distribution
- Recall date
- July 31, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)