The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0858-2022·Announced 2022-04-13

GE Healthcare MRI Systems May Display Flipped Images Affecting Diagnosis

GE Healthcare's 1.5T and 3.0T SIGNA Excite HD MRI systems may display medical images flipped left to right, potentially affecting diagnostic accuracy. The recall involves 76 units distributed worldwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 an FDA Class II recall for a medical device where the hazard—image inversion during diagnostic imaging—creates risk of diagnostic error and compromised patient care. No injuries or illnesses have been reported.

Plain-English summary

GE Healthcare, LLC has issued a recall for its 1.5T SIGNA Excite HD and 3.0T SIGNA Excite HD Magnetic Resonance Imaging (MRI) systems. The devices may display medical images with left-to-right inversion, altering image orientation from the intended display.

Inverted images in diagnostic imaging can affect clinical interpretation and diagnosis. Correct image orientation is critical for accurate identification of findings and appropriate patient care decisions.

The recall affects 76 units distributed worldwide, including the United States and numerous other countries and territories spanning North America, South America, Europe, Asia, Africa, the Middle East, and Oceania.

The recalled product

Product
1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System
Manufacturer
GE Healthcare, LLC
Category
Medical Device — MRI Systems
Hazard
Affected units
76

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)

  • System IDs: 928223MR3T
  • 360397MR2
  • 602406IMR
  • 480323MR1
  • 928SMIMR
  • 3825
  • 559325CIIMR1
  • 805988MR2
  • 6617263TMR
  • 650306SMR3T
  • 4036
  • 3600
  • 3266
  • 818RIMR3T
  • 4267
  • 352333MR3T
  • 407SOMR3T
  • 941PCMR
  • 386HPOMR
  • ALLIANCESIG463

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 →

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