The Recall Desk
HighFDA (Devices)·Z-1943-2013·Announced 2013-08-21

GE Healthcare Recalls Signa MR Systems Due to Patient Data Mismatch Risk

GE Healthcare is recalling multiple Signa MRI systems because a software issue can cause screen save images to be linked to the wrong patient exam, creating a risk of patient data mismatch.

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: The recall is classified as FDA Class II. The hazard involves a risk of patient data mismatch, which is a significant safety issue for a medical device, but the source text does not report any specific injuries, hospitalizations, or deaths, placing it in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Healthcare, LLC is recalling various models of Signa MRI systems, including the Signa Infinity, Signa EXCITE, Signa HDx, and Signa Ovation series. The recall involves 7,016 units distributed worldwide, including 2,919 units in the United States.

The recall is due to a software defect where duplicate Unique Identifiers (UIDs) can be created, causing screen save images to be included in the wrong exam. This error poses a safety risk by potentially leading to a patient data mismatch. While the issue was initially observed at one customer site on a Signa HDxT 1.5T system, an internal investigation determined that the defect impacts multiple GE Healthcare MR systems.

Healthcare facilities and consumers should contact GE Healthcare for instructions on how to resolve the issue. The source text does not specify a particular consumer action beyond the general recall notification, but facilities should verify the serial numbers of their equipment against the provided list to determine if they are affected.

The recalled product

Product
SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM GE SIGNA 3.0T WITH EXCITE MR SYSTEM GE SIGNA EXCITE 1.5T MR SYSTEM GE SIGNA EXCITE 3.0T MR SYSTEM Signa HDx Signa HDxt Signa HDi Signa Vibrant GE 0.35T SIGNA OVAT
Manufacturer
GE Healthcare, LLC
Category
Medical Device — MRI Systems
Hazard

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 (5)

  • Ref. # 60808 "Products: Signa Infinity MR System with EXCITE Technology
  • Signa EXCITE 1.5T and Signa EXCITE 3.0T
  • Signa 3T with EXCITE
  • Signa 3T Infinity with EXCITE
  • GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM (Waukesha

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Related recalls

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Same hazard · data mismatch

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