Evolution Upgrade 1.5T imaging system alignment error recall
Philips Evolution Upgrade 1.5T medical imaging systems may display alignment errors in cross-reference line functionality when reviewing images via 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 describes a potential alignment error in image display functionality with no reported illnesses, injuries, or deaths, and no indication of direct patient harm. The hazard is functional rather than involving patient safety risk of bodily injury or death.
Plain-English summary
Philips North America LLC is recalling the Evolution Upgrade 1.5T imaging system (Model Numbers 782116 and 782148). The devices may exhibit potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
The affected devices were distributed worldwide, including 3 units in the US and 49 units outside the US, across numerous countries. Specific serial numbers for both model variants are identified in the recall documentation.
Users of the affected Evolution Upgrade 1.5T systems with MobiView application should contact Philips North America LLC for guidance on addressing this functionality issue. Healthcare facilities should verify the serial numbers of their equipment against the recall list to determine if their systems are affected.
The recalled product
- Product
- Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;
- 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) 782116
- (2) 782148
- UDI-DI: (1) 00884838099722
- (2) 00884838108714
- Serial Numbers: (1) 41042
- 41047
- 41080
- 41139
- 41229
- 41287
- 41295
- 41327
- 41367
- 41424
- 41432
- 41433
- 41457
- 41568
- 70068
- 70284
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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