MR 7700 Magnetic Resonance System Diagnostic Cable Installation Defect
Philips MR 7700 Magnetic Resonance systems may have an improperly installed diagnostic cable. The cable does not impact system functionality or patient safety.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall involving an installation defect with an explicit statement that the affected cable does not impact system functionality. No injuries or illnesses have been reported, making this a moderate-risk precautionary recall.
Plain-English summary
The FDA has identified a potential installation defect affecting 601 Philips MR 7700 Magnetic Resonance (MR) systems with Product Numbers 782120 and 782130. During installation, a connecting cable between the SmokeDetector Interlock and the host PC may not have been properly installed.
The affected cable is used exclusively for service diagnostics and does not impact the functionality of the MR system, the SmokeDetector Interlock, or patient care. No injuries or illnesses have been reported related to this issue.
The systems affected by this recall have been distributed nationwide and globally. Further information is available from the FDA and the manufacturer, Philips North America.
The recalled product
- Product
- MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
- Manufacturer
- Philips North America
- Hazard
- installation-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Product Number: 782120: UDI-DI: 00884838104112
- Product Number 782130: UDI-DI: 00884838104402
- Serial Numbers: 4530145298 45007 45297
Distribution
Distributed nationwide across the United States.
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