GE Revolution CT The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at differen
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling 197 Revolution CT patient tables worldwide due to a potential safety issue where the cradle can descend on its own after being activated by a user, particularly in cases involving large patients. This unintended motion creates a risk of hand impingement or crushing if a hand becomes caught between the cradle and the CT scanner's inner gantry bore. The affected systems have been distributed across numerous locations in the United States and internationally, including countries such as Canada, Australia, Japan, and throughout Europe.
The record does not specify what remedy or action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
GEHC has become aware of a potential safety issue in the Revolution CT Patient Table that can result in unintended motion in cases involving large patients. The Revolution CT cradle can descend on its own after activation by the user. This can put the patient at risk for harm. The harm can involve the impinging or crushing of a hand if caught between the cradle and CT inner gantry bore. No injurie
Reason for recall: GEHC has become aware of a potential safety issue in the Revolution CT Patient Table that can result in unintended motion in cases involving large patients. The Revolution CT cradle can descend on its own after activation by the user. This can put the patient at risk for harm. The harm can involve the impinging or crushing of a hand if caught between the cradle and CT inner gantry bore. No injurie Distribution: Worldwide Distribution: US (nationwide) including states of: AL, CA, CT, FL, GA, HI, IL, IN, KS, NE, NY,NC, OH, OR, PA, TN, TX, UT, A, WA, WI; and countries of: Australia, Belgium, Brazil, Canada, China, Denmark, Estonia, France, Germany, Hong Kong, Indonesia, Italy, Japan, Korea (Republic of), Kuwait, Mexico, New Zealand, Norway, Peru, Poland, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Quantity: 197 (US = 68; OUS = 129) Lot/code info: Mfg Lot or Serial # System ID 00000437624CN0 N/A 00000439694CN1 N/A 00000439777CN4 N/A 00000439930CN9 N/A 00000441224CN3 203688ERREV1 00000441575CN8 N/A 00000441624CN4 N/A 00000441648CN3 N/A 00000441916CN4 469841REVO 00000442032CN9 N/A 00000442124CN4 N/A 00000442219CN2 N/A 00000442443CN8 N/A 00000443993CN1 N/A 00000444530CN0 N/A 00000445085CN4 N/A 00000438756CN9 309655REVCT 00000439113CN2 212241REVCT 00000439205CN6 415476MCT3 00000439287CN4 415476MCT2 00000439836CN8 215662CTREV 00000440713CN6 815226RVCT 00000441459CN5 206320REV 00000441716CN8 808522RCT 00000442228CN3 281274REV 00000442994CN0 919684REVCT 00000443379CN3 608263REVCT 00000443664CN8 409772CT7 00000443900CN6 402481BEREVCT 00000444165CN5 AM14CFI65 00000444175CN4 801507REV 00000444253CN9 704384REV 00000444745CN4 808KMCCT 00000444872CN6 316268REVCT 00000445059CN9 310222REVO 438369CN1 206598REV1 438902CN9 801662REV1 439823CN6 408356RV1 439835CN0 503216SREV 441040cn3 215952CTREV 441064CN3 256HHRCT1 441066CN8 414805REVCT 441262CN3 RMHCTREV 441990CN9 206598ERREV 442592CN2 205699CTREV 442706CN8 727398REVO 443069CN0 404616CTR 443227CN4 940898REVO 443327CN2 858824REVCT 444398CN2 731541REVCT 444409CN7 386REVCT3 444840CN3 760940REVCT 444913CN8 206288SCREV 00000437624CN0 786596WKRIVO 00000439777CN4 703698REVOCT 00000439930CN9 715847RCT1 00000442124CN4 408498RV2 443327CN2 858824REVCT 00000441624CN4 217876REVO1 00000445085CN4 713792ACT35 00000441575CN8 847437ACT7 442032CN9 512DELLCT 00000442994CN0 N/A 3993CN1 972566OPREVO 445084C
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.