MR 7700 Medical Imaging Device: Alignment Error in Cross Reference Review
Philips MR 7700 medical imaging devices may have alignment errors when reviewing cross reference lines in images generated with the MobiView application. This could affect diagnostic accuracy.
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 an FDA Class II recall with no reported injuries or illnesses. The hazard is a potential alignment error in medical imaging that could affect diagnostic accuracy, but no confirmed harm has been reported. Class II recalls without reported injury typically fall in the moderate severity range.
Plain-English summary
The Philips MR 7700 medical imaging device (model numbers 782120 and 782153) has been recalled due to potential alignment errors in the cross reference line functionality when using the MobiView application. Users may experience misalignment of cross reference lines when reviewing images generated with this application.
Approximately 72 units of the affected device have been distributed worldwide, including 6 units in the United States. International distribution includes countries across Europe, Asia, the Middle East, Latin America, and Africa.
Affected customers should contact Philips North America LLC for information regarding this issue and any available remediation measures.
The recalled product
- Product
- Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;
- Manufacturer
- Philips North America Llc
- Hazard
- alignment-error
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 (20)
- Model Numbers: (1) 782120
- (2) 782153
- UDI-DI: (1) 00884838104112
- (2) 00884838112858
- Serial Numbers: (1) 65000
- 65001
- 65002
- 65003
- 65004
- 65005
- 65007
- 65008
- 65009
- 65011
- 65012
- 65013
- 65014
- 65017
- 65018
- 65019
Distribution
Distributed nationwide across the United States.
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