Philips MR 7700 Medical Device Alignment Error in MobiView Application
Philips is recalling MR 7700 model medical devices due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a medical device with a functional error that could affect diagnostic image interpretation. The source text does not report any illnesses or injuries, but the alignment error in image review functionality presents a risk of harm through potential misdiagnosis.
Plain-English summary
Philips North America LLC is recalling the MR 7700 medical device, model numbers 782120 and 782153, due to a potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
The affected devices are identified by specific serial numbers and have been distributed worldwide, including in the United States and numerous other countries. A total of 72 units have been distributed (6 in the US and 66 outside the US).
Users who have this device should contact Philips North America LLC for instructions on addressing this issue.
The recalled product
- Product
- Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;
- Manufacturer
- Philips North America Llc
- Hazard
- alignment-error
- image-quality-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 (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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