GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications
Check against the official notice below — it lists the full affected range.
GE Medical Systems is recalling 26 GE Revolution CT systems worldwide due to a manufacturing defect. An out-of-tolerance torque tool was used on three joints during manufacturing of these systems, which are used for head, whole body, cardiac, and vascular X-ray computed tomography applications. If the X-ray tube becomes loose on the CT gantry during operation, this could result in beam tracking errors, potential scan aborts, and/or image artifacts. A secondary safety mechanism is in place to prevent components from being expelled from the gantry if the bolts fail.
Four affected systems are located in the United States (in Florida, Georgia, North Carolina, and Texas), and 22 are distributed internationally across Australia, Canada, China, France, Germany, Italy, Japan, South Korea, Norway, Peru, Sweden, the United Arab Emirates, and the United Kingdom. The source document does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
An out of tolerance torque tool was used on three joints during the manufacturing process. If the X-ray Tube becomes loose on the CT gantry during operation, this could result in beam tracking errors, potential scan aborts and/or a possible image artifact. There is a secondary safety mechanism to prevent components from being expelled from the gantry if the bolts fail.
Reason for recall: An out of tolerance torque tool was used on three joints during the manufacturing process. If the X-ray Tube becomes loose on the CT gantry during operation, this could result in beam tracking errors, potential scan aborts and/or a possible image artifact. There is a secondary safety mechanism to prevent components from being expelled from the gantry if the bolts fail. Distribution: Worldwide Distribution - US including FL, GA, NC, and TX and Internationally to AUSTRALIA, CANADA, CHINA, FRANCE, GERMANY, ITALY, JAPAN, REPUBLIC OF KOREA, NORWAY, PERU, SWEDEN UNITED ARAB EMIRATES, UNITED KINGDOM. Quantity: 26 (US = 4;OUS = 22) Lot/code info: Mfg Lot or Serial # System ID 442706CN8 727398REVO 443227CN4 940898REVO 00000442994CN0 919684REVCT 443069cn0 404616CTR 00000442968CN4 83141966438 443342CN1 905521RCT1 00000444648CN0 82421100836 00000442479CN2 82421190324 00000443071CN6 82421300072 00000443308CN2 82421040370 00000444206CN7 82421160425 00000442792CN8 M5480791 00000443675CN4 410014CT04 00000443869CN3 A51773126 00000442785CN2 REV015 00000443501CN2 REV013 00000442940CN3 850210884 00000443590CN5 850210890 00000442289CN5 NO1031CT01 00000444156CN4 CT444156CN4 00000442748CN0 CT442748CN0 00000443952CN7 R002CT09 00000443540CN0 A201CT03 00000444038CN4 AE1015CT02 00000443409CN8 00145CTS01 00000443994CN9 00095CTS04
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.