The Recall Desk
HighFDA (Devices)·Z-0857-2022·Announced 2022-04-13

Signa 1.5T MRI System Recall: Potential Horizontal Image Reversal

GE Healthcare is recalling 10 Signa 1.5T TwinSpeed MRI systems worldwide due to a potential defect where magnetic resonance images may be flipped left to right.

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 with a potential defect affecting diagnostic image orientation. While the defect is theoretical with no reported illnesses or injuries documented, it presents a risk-of-harm to patient care through compromised diagnostic accuracy. The absence of confirmed harm with a theoretical hazard places it in the High severity tier per the rubric.

Plain-English summary

GE Healthcare, LLC is recalling the Signa 1.5T TwinSpeed Magnetic Resonance Imaging System due to a potential defect: the system's images may be flipped horizontally from left to right.

The recall involves 10 units distributed worldwide to the United States and numerous international locations, including Canada, Mexico, the United Kingdom, Germany, France, Italy, Japan, Brazil, and Australia, among others across multiple continents.

Image orientation is essential to diagnostic accuracy in MRI systems, making this potential defect significant for affected healthcare facilities using the recalled equipment.

The recalled product

Product
Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Diagnostic Imaging
Hazard
Affected units
10

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 (10)

  • System IDs: MMIMR01
  • 213748HDMR
  • 714125MR
  • 561218MR1
  • 918523MR1
  • 304766MR1
  • 082427030026
  • 082427080007
  • 082427020017
  • 376569401MR

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by GE Healthcare, 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.

See all 4 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

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