Evolution upgrade 1.5T- Magnetic Resonance recall
Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF)…
Why was Evolution upgrade 1.5T- Magnetic Resonance recalled?
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
UDI-DI: N/A Serial Numbers: 41130 70284 41047 41196 41520 70068 70630 41024 41025 41051 41139 41143 41144 41235 41286 41327 41349 41367 41424 41432 41433 70099 70202 81073 41344 41042 41229 41457 41497 41413 84370 41080 70205 41295 70996 70589 70696 81021 41179 41041 41089 41189 41226 41287 70093 41311 70260 41464 41534 70652 41011 70067 70622 70769 70983
- Product
- Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF)…
- Recalling firm
- Philips North America Llc
- Quantity
- 56 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.
- Recall date
- May 29, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)