Ingenia Elition X systems recalled over elastography stiffness value errors
Philips North America is recalling 31 units of the Ingenia Elition X MR system because exported MR Elastography stiffness maps may show stiffness value errors.
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: Scored 3 under the risk-of-harm criterion: the firm states exported elastography maps may show incorrect stiffness values, and no injuries are reported.
Plain-English summary
The Philips Ingenia Elition X, product codes 781358, 782107 and 782136, covering MR systems with software versions R11.1 and R12.1, is being recalled by Philips North America.
The reason given in the enforcement record is the potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps in a viewer Picture Archiving and Communication System (PACS).
The record lists 31 units, with UDI-DI codes and serial numbers recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States across the states listed in the record. The FDA has classified the action as Class II.
An incorrect stiffness value is a measurement a clinician reads. The enforcement record reports no injuries. Facilities should follow Philips' instructions.
The recalled product
- Product
- Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.
- Manufacturer
- Philips North America
- Category
- Medical Device — MRI
- Hazard
- measurement-error
- elastography
- pacs-export
- mri
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)
- MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781358
- UDI-DI: 00884838088115
- Serial Numbers: 45414
- 45245
- 45090
- 45049
- 45034
- 45250
- 45075
- 45290
- 45320
- 45011
- 45191
- 45277
- 45278
- 45028
- 45147. (2) Product Code (REF): 782107
- UDI-DI: 00884838098336
- Serial Numbers: 62031
- 45533
Distribution
Distributed nationwide across the United States.
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