GE Healthcare: Medical Device Recall in 2015 - (Recall #: Z-0985-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.

Product Classification:

Class II

Date Initiated: December 19, 2014

Date Posted: January 21, 2015

Recall Number: Z-0985-2015

Event ID: 70074

Reason for Recall:

Potential safety issue due to a required torque check on three bolted joints of the Revolution CT scanner. No injuries or illnesses reported.

Status: Terminated

Product Quantity: 13 (7 US, 6 OUS)

Code Information:

Mfg Lot or Serial # System ID 00000437461CN7 519646REVO1 00000437837CN8 M2322254 00000438342CN8 828210096 00000437028CN4 REV001 00000438864CN1 900010CT06 00000439199CN1 260010CT19 00000439068CN8 AE1477CT01 00000437787CN5 786596WKRIVO 00000438503CN5 206598REV1 00000438951CN6 309655REVCT 00000439029CN0 801662REV1 00000439160CN3 212241REVCT 00000439367CN4 415476MCT3

Distribution Pattern:

US: FL, WA, IL, UT, NY, CA. OUS: Canada, France, Hong Kong, Japan, Switzerland, United Arab Emirates.

Voluntary or Mandated:

Voluntary: Firm initiated