Skip to content
Recall Observatory FDA recall evidence

Device product

GE Healthcare Lightspeed RT16 X-ray system

Z-2189-2017

May 19, 2017

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 77377
Status
Terminated
Classification
Class II
Quantity
10,884
Official record key
device-enforcement:Z-2189-2017

Official wording

Reason: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Code information: n/a

Distribution pattern: Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritania, Mexico, Moldova, Morocco, Nambia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietam and Yemen.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.