Class 2 Device Recall GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High Capacity Table, Lite Table, Kunlun Table

• Date Initiated by Firm: June 02, 2022
• Date Posted: August 10, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1511-2022
• Recall Event ID: 90368
• Product Classification: Table, radiographic, non-tilting, powered - Product Code IZZ
• Product: 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.
• Code Information: Following are the service manual revision numbers and the GTINs for the associated systems: (1) Service manual identifier 5193754-800, Rev 23 and prior, GTIN: N/A; (2) Service manual identifier 5307450-2EN, Rev 30 and prior, GTIN: Revolution Discovery CT: 00840682102490; Revolution Discovery CT A: 00840682125574; Revolution HD: N/A; Discovery CT750 HD: N/A; Discovery CT: N/A. NOTE: Revolution Discovery CT has two different GTINs to identify different versions of the device. (3) Service manual identifier 5350500-8EN, Rev 28 and prior, GTIN: Optima CT540: 00840682102551; Optima CT540 N: 00840682138963. Note: Optima CT540 has two different GTINs to identify different versions of the device. (4) Service manual identifier 5836560-8EN, Rev 2 and prior, GTIN: 00195278563408. (5) Service manual identifier 5366080-8EN, Rev 39 and prior, GTIN: Optima CT660 Cj2.5 Upgrade: 00840682116510. (6) Service manual identifier 5487410-8EN, Rev 14 and prior, GTIN: N/A. (7) Service manual identifier 5809950-8EN, Rev 3 and prior, GTIN: Revolution Maxima: 00840682146180; Revolution Maxima US: 00840682147392; Revolution Ace: 00840682146159; Optima CT680 Expert: 008406821469372; Revolution Maxima M: N/A. (8) Service manual identifier 5848536-8EN, Rev 1 and prior, GTIN: 00195278420893. (9) Service manual identifier 5796213-2EN, Rev 8 and prior, GTIN: 00840682137553. (10) Service manual identifier 5366638-8EN, Rev 24 and prior, GTIN: Discovery RT: 00840682118699, Discovery CT590RT and CT580: N/A. (11) Service manual identifier 5196837-800, Rev 12 and prior, GTIN: N/A. (12) Service manual identifier 5193574-800, Rev 36 and prior, GTIN: 00840682105286. (13) Service manual identifier 5193574-800, Rev 36 and prior, GTIN: N/A. (14) Service manual identifier 5866660-8EN, Rev 26 and prior, GTIN: 00840682109796. (15) Service manual identifier 5987660-8EN, Rev3 and prior, GTIN: 00840682146173. (16) Service manual identifier 5307450-2EN, Rev 30 and prior, GTIN: Revolution Discovery CT: 00840682102490; Revolution Discovery CT A: 00840682125574; Revolution HD: N/A; Discovery CT750 HD: N/A; Discovery CT: N/A. NOTE: Revolution Discovery CT has two different GTINs to identify different versions of the device. (17) Service manual identifier 5366080-8EN, Rev 39 and prior, GTIN: Optima CT660 Cj2.5 Upgrade: 00840682116510. (18) Service manual identifier 5809950-8EN, Rev 3 and prior, GTIN: Revolution Maxima: 00840682146180; Revolution Maxima US: 00840682147392; Revolution Ace: 00840682146159; Optima CT680 Expert: 008406821469372; Revolution Maxima M: Not applicable. NOTE: Revolution Maxima has two different GTINs to identify different versions of the device. (19) Service manual identifier 5796213-2EN, Rev 8 and prior, GTIN: 00840682137553. (20) Service manual identifier 5196837-800, Rev 12 and prior, GTIN: N/A. (21) Service manual identifier 5661743-2EN, Rev 9 and prior, GTIN: Discovery MI weldment: 00840682143523; Discovery MI non-weldment: 00840682108218; Discovery MI Gen2: 00195278098603. NOTE: Discovery MI has three different GTINs to identify different versions of the device. (22) Service manual identifier 5146686-2EN, Rev 7 and prior, GTIN: Discovery MI-DR non-weldment: 00840682120975; Discovery MI-DR weldment: 00840682146166. NOTE: Discovery MI-DR has two different GTINs to identify different versions of the device. (23) Service manual identifier 5495002-2EN, Rev 11 and prior, GTIN: 00840682125703. (24) Service manual identifier 5428822-2EN, Rev 5 and prior, GTIN: Discovery 610: 00840682103053; Discovery 710: 00840682102995. (25) Service manual identifier 5440658-2EN, Rev 5 and prior, GTIN: Discovery 610: 00840682103053; Discovery 710: 00840682102995; Optima 560: N/A. (26) Service manual identifier 5322777-2EN, Rev 12 and prior, GTIN: Discovery 600 Upgrade: 00840682143981; Discovery 690 Elite: N/A; Optima 560: N/A. (27) Service manual identifier 5266353-2EN, Rev 14 and prior, GTIN: N/A. (28) Service manual identifier 5193574-800, Rev 36 and prior, GTIN: 00840682105286. (29) Service manual identifier 5193574-800, Rev 36 and prior, GTIN: N/A. (30) Service manual identifier 5866660-8EN, Rev 26 and prior, GTIN: 00840682109796. (31) Service manual identifier 5987660-8EN, Rev 3 and prior, GTIN: 00840682146173. (32) Service manual identifier 5307450-2EN, Rev 30 and prior, GTIN: Revolution Discovery CT: 00840682102490; Revolution Discovery CT A: 00840682125574; Revolution HD: N/A. (33) Service manual identifier 5796213-2EN, Rev 8 and prior, GTIN: 00840682137553. (34) Service manual identifier 5366080-8EN, Rev 39 and prior, GTIN: Optima CT660 Cj2.5 Upgrade: 00840682116510. (35) Service manual identifier 5866660-8EN, Rev 26 and prior, GTIN: 00840682109796. (36) Service manual identifier 5987660-8EN, Rev 3 and prior, GTIN: 00840682146173. (37) Service manual identifier 5116374, Rev 21 and prior, GTIN: N/A. (38) Service manual identifier 2326233, Rev 17 and prior, GTIN: N/A. (39) Service manual identifier 5661743-2EN, Rev 9 and prior, GTIN: Discovery MI weldment: 00840682143523; Discovery MI non-weldment: 00840682108218; Discovery MI Gen2: 00195278098603. NOTE: Discovery MI has three different GTINs to identify different versions of the device. (40) Service manual identifier 5146686-2EN, Rev 7 and prior, GTIN: Discovery MI-DR non-weldment: 00840682120975; Discovery MI-DR weldment: 00840682146166. NOTE: Discovery MI-DR has two different GTINs to identify different versions of the device. (41) Service manual identifier 5495002-2EN, Rev 11 and prior, GTIN: 00840682125703. (42) Service manual identifier 5428822-2EN, Rev 5 and prior, GTIN: Discovery 610: 00840682103053; Discovery 710: 00840682102995. (43) Service manual identifier 5440658-2EN, Rev 5 and prior, GTIN: Discovery 610: 00840682103053; Discovery 710: 00840682102995; Optima 560: N/A. (44) Service manual identifier 5322777-2EN, Rev 12 and prior, GTIN: Discovery 600 Upgrade: 00840682143981; Discovery 690 Elite: N/A; Optima 560: N/A. (45) Service manual identifier 5266353-2EN, Rev 14 and prior, GTIN: N/A. (46) Service manual identifier 5366638-8EN, Rev 24 and prior, GTIN: Discovery RT: 00840682118699, Discovery CT590RT; Optima CT580: N/A. (47) Service manual identifier 5196837-800, Rev 12 and prior, GTIN: N/A. (48) Service manual identifier 5478834-1EN, Rev 6 and prior, GTIN: N/A. (49) Service manual identifier 5458022-8EN, Rev 15 and prior, GTIN: N/A (50) Service manual identifier 5487206-8EN, Rev 8 and prior, GTIN: Revolution ACT: 00840682135313; Revolution ACT LMB: 00840682146197, Revolution ACT EL: 00195278568373, Revolution ACTs: 00195278534811; Revolution Star: N/A; Revolution Star ES: N/A; ACT: N/A; ACTs: N/A. (51) Service manual identifier 2244773, Rev 36 and prior, GTIN: N/A. (52) Service manual identifier 5181178-800, Rev 24 and prior, GTIN: N/A. (53) Service manual identifier 5411810-8EN, Rev 10 and prior, GTIN: Optima CT520: 00840682102568. (54) Service manual identifier 5457941-8EN, Rev 16 and prior, GTIN: Optima CT520: 00840682102568; Optima Advance: 00840682147415. (55) Service manual identifier 5836560-8EN, Rev 2 and prior, GTIN: 00195278563408. (56) Service manual identifier 5366080-8EN, Rev 39 and prior, GTIN: Optima CT660 Cj2.5 Upgrade: 00840682116510. (57) Service manual identifier 5487410-8EN, Rev 14 and prior, GTIN: N/A. (58) Service manual identifier 5809950-8EN, Rev 3 and prior, GTIN: Revolution Maxima: 00840682146180; Revolution Maxima US: 00840682147392; Revolution Ace: 00840682146159; Optima CT680 Expert: 008406821469372; Revolution Maxima M: N/A. NOTE: Revolution Maxima has two different GTINs to identify different versions of the device. (59) Service manual identifier 5850006-8EN, Rev 1 and prior, GTIN: Revolution Advance: 00195278385215; Revolution Eagle: 00195278403087. (60) Service manual identifier 2188543, Rev 44 and prior, GTIN: N/A. (61) Service manual identifier 2244773, Rev 36 and prior, GTIN: N/A.
• Recalling Firm/ Manufacturer: GE Healthcare, LLC; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: GE Healthcare Service; 800-437-1171
• Manufacturer 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.
• FDA Determined Cause: Error in labeling
• 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.
• Quantity in Commerce: 24,843 tables
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.