GE Healthcare, LLC: Medical Device Recall in 2017 - (Recall #: Z-2188-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

GE Healthcare BrightSpeed X-ray system

Product Classification:

Class II

Date Initiated: May 19, 2017

Date Posted: June 21, 2017

Recall Number: Z-2188-2017

Event ID: 77377

Reason for Recall:

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

Status: Terminated

Product Quantity: 10,884

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.

Voluntary or Mandated:

FDA Mandated