Ingenia 1.5T Evoluton- Magnetic Resonance Medical recall
Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional…
Why was Ingenia 1.5T Evoluton- Magnetic Resonance Medical recalled?
Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury
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?
S/N and UDI: US: 61044 (01)00884838099715(21)61044; 61047 (01)00884838099715(21)61047. OUS: 61028 (01)00884838099715 61008 (01)00884838099715 61025 (01)00884838099715 61026 (01)00884838099715 61034 (01)00884838099715 61035 (01)00884838099715 61042 (01)00884838099715 61046 (01)00884838099715 61040 (01)00884838099715 61041 (01)00884838099715 61018 (01)00884838099715 61017 (01)00884838099715 61032 (01)00884838099715 61043 (01)00884838099715 61033 (01)00884838099715 61064 (01)00884838099715
- Product
- Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional…
- Recalling firm
- Philips North America Llc
- Quantity
- 2 units US; 16 units OUS
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, MD, MD, NH, NY, OH, TN, TX, VA and the countries of Canada, Mexico, Australia, Austria, Chile, China, Czech Republic, Denmark, France, Germany, India, Indonesia, Italy, Japan, Korea, Republic of Lebanon, Netherlands, Romania, Russian Federation, Saudi Arabia, Spain, Turkey, Ukraine, United Kingdom.
- Recall date
- September 1, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)