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.
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling 24,843 CT, PET, and NM tables distributed nationwide in the US, Puerto Rico, and internationally due to a hazard in their service manuals. The unclear guidance in the manuals can result in service personnel removing the wrong screws during maintenance without proper table supports in place, which may cause the table to drop and injure workers.
The affected equipment includes multiple models such as the GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High Capacity Table, Lite Table, and various other models from GE's CT, PET, and nuclear medicine product lines. The source document does not specify what remedy or corrective action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: 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, Ch Quantity: 24,843 tables Lot/code info: 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) Se
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.