AXIOM Luminos dRFsystem The Axiom Luminos dRF is recall
AXIOM Luminos dRFsystem The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic…
Why was AXIOM Luminos dRFsystem The Axiom Luminos dRF is recalled?
It was determined that under rare environmental conditions (i.e., extremely dry air in combination with a highly isolated floor) electrostatic discharges (ESD) >8 kV may trigger an unintended movement of the AXIOM Luminos dRFsystem which may lead to an emergency situation and pose danger to the patients, operating personnel or to the unit.
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?
Model number: 10094200, serial numbers:4332 4291 4323 4430 3061 4331 4238 4297 4201 4024 3098 4252 4372 4354 4077 3050 3108 4327 4342 4251 3053 3114 4156 3145 3096 4043 3181 4208 3090 4143 4051 4199 4401 4405 4151 4373 4276
- Product
- AXIOM Luminos dRFsystem The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 37
- Distribution
- Class II Recall - US Distribution including the states of IL,VA, TN, PA, TX, MN, GA, MI, IN, OH, FL, CA, OR, NY, ME, MO, OK, CO and NJ.
- Recall date
- June 11, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)