Skip to content

SIGNA Architect - Product Usage: is a whole body magnetic… recallZ-2053-2021 · GE Healthcare, LLC · initiated Jun 4, 2021

Class II Open, Classified All recalls posted in July 2021

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from GE Healthcare, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

FDA root cause category: Software design

What the company is doing

Deployment of the original customer letter to consignees in the U.S. began on June 4, 2021. Dissemination of the updated customer letter to consignees in the U.S. began on June 11, 2021. The letters discuss an issue on the affected products listed below where the Patient Orientation button may inadvertently be clicked when intending to click on the Save RX button. Users are directed to review and confirm that the actual patient orientation matches the prescribed patient orientation before initiating the scan. A correction is planned.

Recall details

Recall number
Z-2053-2021
Recall class
Class II
Status
Open, Classified
Initiated by the company
Jun 4, 2021
Posted by the FDA
Jul 12, 2021
Recalling firm
GE Healthcare, LLC
Quantity
311 devices
Product code
LNH
FDA submissions
K160618, K163331, K202966
Distribution
Worldwide distributions.

Product description

SIGNA Architect - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

Code information (models, lots, serial numbers)

N/A

Other devices under the same FDA submission

10 devices cleared under K160618, K163331, K202966 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 88147).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page