—#145806

Product

GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K133705
Affected 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

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

GE Healthcare Systems sent an Urgent Medical Device Correction letter dated April 20, 2016, to all affected consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Recalling firm

Firm: GE Medical Systems, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2016-04-20
Posted by FDA: 2016-04-29
Terminated: 2016-09-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #145806. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.