Open, Classified

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Voyager and SIGNA Voyager Premier Edition system, nuclear magnetic resonance imaging system.

FDA Recall Z-0599-2022 · Posted None

Recall StatusOpen, Classified

Product CodeLNH

Date Initiated2021-12-23

Product Quantity17,228 devices total in this field correction

Reason for Recall

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Firm Action

The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.

Root Cause

Process control

Distribution Pattern

Distribution was nationwide, including Puerto Rico and the Virgin Islands. There was also government and military distribution. Foreign distribution was made to Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaidjan, Bahrain, Bangladesh, Belarus, Belgium, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Republic of Congo, Croatia, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, Equatorial Guinea, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Kyrhyzstan, Latvia, Lebanon, Libyan Arabic Jamahiriya, Lithuania, Luxembourg, Macedonia, Madagascar, Malaysia, Mali, Malta, Mauritania, Mexico, Republic of Moldova, Morocco, Mozambique, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Nordic-HQ, Norway, Oman, Pakistan, State of Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Swaziland, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, Zambia, and Zimbabwe.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K192426Signa Voyager, Signa Voyager QuantumGe Healthcare (Tianjin) Company Limited · 2019-10-01 K161567SIGNA VoyagerGE Healthcare · 2016-09-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.