Optima CT540 NRecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

9 other recalls cover devices cleared under the same FDA submission (K082816); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 2, 2022Open, Classified

   As a result of unclear guidance in the service manual, the table can drop during a specific service activity if the wrong screws are removed by the service personnel without the appropriate table supports in place resulting in injury to service personnel.

   Z-1511-2022 · Root cause: Error in labeling · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082816. One submission often covers many models, so check the product and lot details in each record.

• Z-2586-2018 · May 24, 2018 · Terminated
  Optima CT 540
• Z-2873-2018 · Apr 27, 2018 · Terminated
  GE Healthcare Optima CT660. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold only outside the U.S. under the follow
• Z-2872-2018 · Apr 27, 2018 · Terminated
  GE Healthcare Optima CT540. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.Sold under the following product names: BE
• Z-2186-2017 · May 19, 2017 · Terminated
  GE Healthcare Optima CT540 X-ray system
• Z-2188-2017 · May 19, 2017 · Terminated
  GE Healthcare BrightSpeed X-ray system
• Z-0840-2014 · Oct 9, 2013 · Terminated
  GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data t
• Z-2214-2011 · Jan 19, 2011 · Terminated
  BrightSpeed Excel Select, BrightSpeed Edge Select ,BrightSpeed Elite Select and BrightSpeed Elite Computed Tomography X-ray systems with software version 09BW35.11 or 09HW30.4. Th
• Z-0369-2011 · Sep 3, 2010 · Terminated
  GE BrightSpeed Excel/Edge/Elite Select / Elite CT Scanner System, models 2377708-560, 5377708-540, 5377708-560. Composed of a gantry, patient table, operator console, computer, an
• Z-0368-2011 · Sep 3, 2010 · Terminated
  GE LightSpeed VCT Scanner System, models 5212920-300, 5212920-310, 5311595-10. Composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisit