Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000, GT...
FDA Device Recall #Z-1511-2022 — Class II — June 2, 2022
Recall Summary
| Recall Number | Z-1511-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 2, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Healthcare, LLC |
| Location | Waukesha, WI |
| Product Type | Devices |
| Quantity | 24,843 tables |
Product Description
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.
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.
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.
Lot / 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.
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| Z-1430-2022 | Class II | SIGNA Premier magnetic resonance scanner, model... | Jun 24, 2022 |
| Z-1466-2022 | Class II | Centricity PACS Software Version 7.0 SP0.0.4.7 | Jun 14, 2022 |
| Z-1333-2022 | Class II | GE Centricity Universal Viewer Zero Footprint. ... | Jun 8, 2022 |
| Z-1389-2022 | Class I | GE Healthcare Aisys CS2 Anesthesia System, Part... | Jun 1, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.