Z-2188-2017 Class II Terminated
FDA device recall Z-2188-2017 was initiated by GE Healthcare, LLC on May 19, 2017 and is designated Class II. 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. The recall status is terminated (terminated July 29, 2018). Affected quantity: 10,884.
Recall Details
- Product Type
- Devices
- Report Date
- June 21, 2017
- Initiation Date
- May 19, 2017
- Termination Date
- July 29, 2018
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 10,884
Product Description
Reason for Recall
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.