Ingenia 3.0T - For use as a diagnostic device to obtain recall
Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the…
Why was Ingenia 3.0T - For use as a diagnostic device to obtain recalled?
Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.
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: (01)00884838098299(21) Serial Numbers: 85625 85626 85628 85630 85633 85637 85638 85641 85642 85646 85650 85652 85653 85654 85656 85657 85658 85659 85660 85662 85664 85666 85667 85668 85672 85674 85682 85683 85686 85692 85696 85701 85713
- Product
- Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the…
- Recalling firm
- Philips North America Llc
- Quantity
- 33 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Iceland, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Maldives, Mauritius, Mexico, Morocco, Netherlands, Pakistan, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Switzerland, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Uzbekistan, Vietnam.
- Recall date
- October 2, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)