Skip to content

Tomographic Imager Combining Emission Computed Tomography… recallZ-0520-2025 · GE Medical Systems, LLC · initiated Oct 28, 2024

Open, Classified

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 Medical Systems, 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

Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.

FDA root cause category: Device Design

What the company is doing

GE Healthcare issued an "URGENT MEDICAL DEVICE CORRECTION" notice to its consignees on 10/28/20224 delivered through a traceable means. The notice explained the issue, safety issue, and requested the following actions be taken for the continued safe usage of the affected devices: "Ensure hearing protection with a Noise Reduction Rating (NRR) of at least 33dB is used during exams on these systems. 200 pairs are provided with this letter. Please post this letter in your facility on or near the MR operator console. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records." Please complete and return the attached acknowledgement form to [email protected]. For questions or concerns, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

Recall details

Recall number
Z-0520-2025
Status
Open, Classified
Initiated by the company
Oct 28, 2024
Posted by the FDA
Nov 22, 2024
Recalling firm
GE Medical Systems, LLC
Quantity
2 units
Product code
LNH
FDA submissions
K163619, K213709, K142098
Distribution
Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Canada, China, India, Japan, Korea, Latvia, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan.

Product description

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERY PET/MR,

Code information (models, lots, serial numbers)

1) UDI/DI To be provided, System ID 82427070262; 2) UDI/DI To be provided, System ID EX0133

Other devices under the same FDA submission

4 devices cleared under K163619, K213709, K142098 — 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 95735).

Sources and updates

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