Philips Ingenia 1.5T CX MRI System Patient Support Table Installation Defect
Philips has recalled 143 Ingenia 1.5T CX MRI systems due to potential incorrect installation of the patient support table floor plate affecting worldwide distribution.
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: This is a Class II medical device recall for a risk-of-harm product where incorrect installation could affect patient safety. No illnesses or injuries have been reported, making the hazard theoretical rather than confirmed.
Plain-English summary
Philips North America LLC is recalling the Ingenia 1.5T CX Magnetic Resonance System. The recall involves 143 units that were distributed worldwide, including distribution throughout the United States.
The patient support table floor plate may be incorrectly installed. This is the structural component that supports and positions patients during magnetic resonance imaging procedures.
The FDA classified this as a Class II recall.
The recalled product
- Product
- Ingenia 1.5T CX, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Hazard
- installation-defect
- structural-defect
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 No. 781261
- 781262
- UDI-DI 884838068438
- Serial No. Serial Number
- 77000
- 77002
- 77001
- 77004
- 77007
- 77008
- 77010
- 77016
- 77019
- 77030
- 77031
- 77043
- 77032
- 77033
- 77041
- 77034
Distribution
Distributed nationwide across the United States.
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