Home / Recalls / GE Medical Systems, LLC / Z-1046-2025

Z-1046-2025 Class II Ongoing

Recalled by GE Medical Systems, LLC — Waukesha, WI

Recall Details

Product Type
Devices
Report Date
February 12, 2025
Initiation Date
January 28, 2025
Termination Date
N/A
Voluntary/Mandated
FDA Mandated
Product Quantity
3149 (1697 US; 1452 OUS)

Product Description

Optima XR646 HD. X-Ray imaging system.

Reason for Recall

The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.

Distribution Pattern

Worldwide Distribution: US (nationwide) including Puerto Rico and OUS (foreign) countries to: Canada, Chile, China, Colombia, Coast Rica, Croatia, Cyprus, Czech Republic, Czechia, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Gibraltar, Greece, Honduras, Hong Kong, Hungary, Iceland, Indonesia, Iraq, Ireland, Italy, Jamaica, Japan, Jordan, Kenya, Korea (Republic of) Kuwait, Libya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Vietnam.

Code Information

GTIN: 00195278526892

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  • Z-2151-2026 Class II — Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23 (March 26, 2026)
  • Z-2152-2026 Class II — Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25 (March 26, 2026)
  • Z-1590-2026 Class II — Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT) (February 3, 2026)
  • Z-1570-2026 Class II — Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device (January 30, 2026)
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