🔍 RecallPedia

Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808

Class I - Dangerous
🏥 Medical Devices Recalled: April 14, 2026 Philips North America Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    1. Model Number (REF): 781315. UDI: (01)00884838099715(21)61067, (01)00884838099715(21)61058, (01)00884838099715(21)61056. Serial Numbers: 61067 61058, 61056. 2. Model Number (REF): 781341. UDI: (01)00884838055322(21)70229, (01)00884838055322(21)84667, (01)00884838055322(21)70311, (01)00884838055322(21)70668, (01)00884838055322(21)70845, (01)00884838055322(21)70851, (01)00884838055322(21)87151, (01)00884838055322(21)87112, (01)00884838055322(21)84322, (01)00884838055322(21)84323, (01)00884838055322(21)84228, (01)00884838055322(21)84789, (01)00884838055322(21)84261, (01)00884838055322(21)84500, (01)00884838055322(21)84556, (01)00884838055322(21)87187, (01)00884838055322(21)84840, (01)00884838055322(21)70685, (01)00884838055322(21)84661, (01)00884838055322(21)70787, (01)00884838055322(21)70063, (01)00884838055322(21)70621, (01)00884838055322(21)70743, (01)00884838055322(21)70911, (01)00884838055322(21)84049, (01)00884838055322(21)84088, (01)00884838055322(21)84147, (01)00884838055322(21)84254, (01)00884838055322(21)84283, (01)00884838055322(21)84403, (01)00884838055322(21)84433, (01)00884838055322(21)84460, (01)00884838055322(21)84462, (01)00884838055322(21)84467, (01)00884838055322(21)84475, (01)00884838055322(21)84734, (01)00884838055322(21)84538. Serial Numbers: 70229, 84667, 70311, 70668, 70845, 70851, 87151, 87112, 84322, 84323, 84228, 84789, 84261, 84500, 84556, 87187, 84840, 70685, 84661, 70787, 70063, 70621, 70743, 70911, 84049, 84088, 84147, 84254, 84283, 84403, 84433, 84460, 84462, 84467, 84475, 84498, 84538. 3. Model Number (REF): 781396. UDI: (01)00884838009820(21)41175, (01)00884838009820(21)41108, (01)00884838009820(21)41395, (01)00884838009820(21)41037, (01)00884838009820(21)41066, (01)00884838009820(21)41098, (01)00884838009820(21)41194, (01)00884838009820(21)41208, (01)00884838009820(21)41354, (01)00884838009820(21)41356, (01)00884838009820(21)41370, (01)00884838009820(21)41552. Serial Numbers: 41175, 41108, 41395, 41037, 41066, 41098, 41194, 41208, 41354, 41356, 41370, 41552. 4. Model Number (REF): 782115. UDI: (01)00884838099043(21)61214, (01)00884838099043(21)61221. Serial Numbers: 61214, 61221.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Philips North America
Reason for Recall:
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808

Product Codes/Lot Numbers:

1. Model Number (REF): 781315. UDI: (01)00884838099715(21)61067, (01)00884838099715(21)61058, (01)00884838099715(21)61056. Serial Numbers: 61067 61058, 61056. 2. Model Number (REF): 781341. UDI: (01)00884838055322(21)70229, (01)00884838055322(21)84667, (01)00884838055322(21)70311, (01)00884838055322(21)70668, (01)00884838055322(21)70845, (01)00884838055322(21)70851, (01)00884838055322(21)87151, (01)00884838055322(21)87112, (01)00884838055322(21)84322, (01)00884838055322(21)84323, (01)00884838055322(21)84228, (01)00884838055322(21)84789, (01)00884838055322(21)84261, (01)00884838055322(21)84500, (01)00884838055322(21)84556, (01)00884838055322(21)87187, (01)00884838055322(21)84840, (01)00884838055322(21)70685, (01)00884838055322(21)84661, (01)00884838055322(21)70787, (01)00884838055322(21)70063, (01)00884838055322(21)70621, (01)00884838055322(21)70743, (01)00884838055322(21)70911, (01)00884838055322(21)84049, (01)00884838055322(21)84088, (01)00884838055322(21)84147, (01)00884838055322(21)84254, (01)00884838055322(21)84283, (01)00884838055322(21)84403, (01)00884838055322(21)84433, (01)00884838055322(21)84460, (01)00884838055322(21)84462, (01)00884838055322(21)84467, (01)00884838055322(21)84475, (01)00884838055322(21)84734, (01)00884838055322(21)84538. Serial Numbers: 70229, 84667, 70311, 70668, 70845, 70851, 87151, 87112, 84322, 84323, 84228, 84789, 84261, 84500, 84556, 87187, 84840, 70685, 84661, 70787, 70063, 70621, 70743, 70911, 84049, 84088, 84147, 84254, 84283, 84403, 84433, 84460, 84462, 84467, 84475, 84498, 84538. 3. Model Number (REF): 781396. UDI: (01)00884838009820(21)41175, (01)00884838009820(21)41108, (01)00884838009820(21)41395, (01)00884838009820(21)41037, (01)00884838009820(21)41066, (01)00884838009820(21)41098, (01)00884838009820(21)41194, (01)00884838009820(21)41208, (01)00884838009820(21)41354, (01)00884838009820(21)41356, (01)00884838009820(21)41370, (01)00884838009820(21)41552. Serial Numbers: 41175, 41108, 41395, 41037, 41066, 41098, 41194, 41208, 41354, 41356, 41370, 41552. 4. Model Number (REF): 782115. UDI: (01)00884838099043(21)61214, (01)00884838099043(21)61221. Serial Numbers: 61214, 61221.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1956-2026

Related Recalls

Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.

Philips North America

Class I - Dangerous

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

Apr 14, 2026 Other Medical Devices Nationwide View Details →

Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

Philips North America

Class I - Dangerous

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

Apr 14, 2026 Other Medical Devices Nationwide View Details →