Philips MR 5300 Imaging System Alignment Error Recall Worldwide
Philips has recalled the MR 5300 medical imaging system due to potential alignment errors in the cross reference line functionality. These errors could affect image accuracy when reviewing images 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 of a medical device with a functional defect that poses a risk of harm. The alignment error in cross reference line functionality could affect diagnostic image analysis, though no injuries or illnesses have been reported to date. This fits the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Philips North America LLC has recalled the MR 5300 medical imaging system to address a potential software malfunction. The MR 5300 is available in two model numbers (782110 and 782152), and the recall involves 186 units—2 in the United States and 184 distributed internationally.
The issue involves the MobiView application used with these systems. There is potential for alignment errors in the cross reference line functionality when reviewing images generated with this application. Such alignment errors could affect image interpretation accuracy.
Affected healthcare facilities should verify their equipment serial numbers against the official recall notice and contact Philips North America LLC for guidance on corrective action. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;
- 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) 782110
- (2) 782152
- UDI-DI: (1) 00884838099364
- (2) 00884838112841
- Serial Numbers: (1) 63007
- 63011
- 63022
- 63043
- 63047
- 63050
- 63051
- 63060
- 63074
- 63078
- 63079
- 63082
- 63085
- 63090
- 63095
- 63097
Distribution
Distributed nationwide across the United States.
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