Philips Evolution Upgrade 1.5T medical imaging device recalled for alignment errors
Philips is recalling Evolution Upgrade 1.5T imaging devices due to potential alignment errors in the MobiView application's cross-reference line functionality. Misalignment could lead to inaccurate diagnostic positioning information.
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: FDA Class II device with potential for diagnostic error through cross-reference line misalignment in image review software. This is a risk-of-harm medical device where no injuries have been reported, per the severity rubric. The hazard is theoretical but could affect clinical decision-making.
Plain-English summary
Philips North America LLC is recalling the Evolution Upgrade 1.5T medical imaging device (model numbers 782116 and 782148) due to a software defect in the MobiView image review application.
The MobiView application is used to review diagnostic images captured by the device. A defect in the cross-reference line functionality may cause alignment errors when clinicians review medical images. Misalignment of the cross-reference line could result in incorrect positioning information, potentially affecting diagnostic accuracy.
A total of 52 units have been distributed worldwide, including 3 units in the United States and 49 units distributed internationally. Affected devices can be identified by specific serial numbers listed in the official FDA recall notice.
Philips recommends that healthcare facilities using these devices contact the company immediately for corrective action. No reported injuries or illnesses have been associated with this issue to date.
The recalled product
- Product
- Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;
- Manufacturer
- Philips North America Llc
- Hazard
- alignment-error
- diagnostic-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) 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.
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