MR 5300 Medical Device Recall for Cross Reference Line Alignment Error
Philips is recalling MR 5300 medical devices (Model Numbers 782110 and 782152) due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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. The source text explicitly describes a potential functional error in image review functionality with no reported illnesses or injuries, supporting a Moderate classification for this labeling/functional issue without evidence of patient harm.
Plain-English summary
Philips North America LLC is recalling MR 5300 medical devices with Model Numbers 782110 and 782152. The devices may have alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
The recall affects 186 units worldwide, including 2 units in the United States and 184 units distributed internationally. The affected serial numbers for Model 782110 include 63007 through 63599, and for Model 782152 include 69000 through 69176.
Users should contact Philips for instructions on addressing this issue. Healthcare facilities and users of these devices should refer to the FDA recall notice (Z-1804-2025) for complete details and guidance.
The recalled product
- Product
- Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;
- Manufacturer
- Philips North America Llc
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.
Part of a larger recall action
This product is one of 18 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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