GE Medical Systems, LLC: Medical Device Recall in 2016 - (Recall #: Z-1589-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 20, 2016

Date Posted: May 11, 2016

Recall Number: Z-1589-2016

Event ID: 73974

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.

Status: Terminated

Product Quantity: 26 (US = 4;OUS = 22)

Code Information:

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated