Open, Classified

Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High Capacity Table, Lite Table, Kunlun Table, Global PET-CT Table, NP Table, P2005AA Table, LCT Table, CTE TWIN TABLE Assy. All devices are patient tables for PET/CT systems.

FDA Recall Z-1511-2022 · Posted 2022-08-10

Recall StatusOpen, Classified

Product CodeIZZ

Date Initiated2022-06-02

Product Quantity24,843 tables

Reason for Recall

As a result of unclear guidance in the service manual, the table can drop during a specific service activity if the wrong screws are removed by the service personnel without the appropriate table supports in place resulting in injury to service personnel.

Firm Action

The recalling firm issued letters dated 6/2/2022 via traceable means on 6/2/2022 to the following titles within the direct accounts: Director of Clinical / Radiology, Risk Manager / Hospital Administrator, and Director of Biomedical Engineering. The letter explained the safety issue that the table could drop during a specific service activity if the wrong screws are removed by the service personnel without the appropriate table supports in place, resulting in injury to service personnel. The letter reported there is no defect in the table itself and the issue is related to unclear guidance in the service manual for a specific service procedure. The issue can only occur during specific servicing activities on the table. To avoid the issue, the consignee is to contact GE Healthcare Service at the number provided in the letter prior to any table servicing activities so that GE Healthcare can provide the consignee with guidance. The letter contained a link to an acknowledgment form for completion. An appendix was enclosed which listed two tables, Table 1 listed the affected tables and Table 2 listed the affected CT (Computed Tomography), PET (Positron Emission Tomography) and NM (Nuclear Medicine) systems which use the tables. The letter informed the consignee that GE Healthcare will provide an updated service manual with specific instructions regarding safe servicing of the impacted tables. The service manual updates are planned to be released by the end of June 2022. Appendix B in the letter provides instructions on accessing the latest service manuals online.

Root Cause

Error in labeling

Distribution Pattern

US Nationwide distribution including PR. There was also government/military distribution. The countries of Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Plurinational State of Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Chile, China, Colombia, Costa Rica, Cote D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Kyrgyzstan, Lao PDR, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Mali, Martinique, Mauritania, Mexico, Moldova, Morocco, Mozambique, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, Somalia, South Africa, Spain, Sri Lanka, Sudan, Swaziland, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Togo, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Bolivarian Republic of Venezuela, Viet Nam, Yemen, and Yugoslavia.

Official Source

View FDA Recall →

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