Optima XR646 HD. X-Ray imaging system.
Enforcement
- Recall Number
- Z-1046-2025
- Event ID
- 96208
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- GE Medical Systems, LLC
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- February 12, 2025
- Initiation Date
- January 28, 2025
- Classification Date
- February 3, 2025
- Address
- 3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States
Description
Optima XR646 HD. X-Ray imaging system.
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.
GTIN: 00195278526892
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.
3149 (1697 US; 1452 OUS)