Z-0985-2015Class II

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

Name: Z-0985-2015 GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner
Creator: GE Healthcare
Published: 2014-12-19
License: https://open.fda.gov/license/

GE Healthcare / initiated 2014-12-19 / Terminated / root cause: manufacturing process

FDA source

GE Healthcare began a recall of GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner on 2014-12-19. FDA classified it as Class II and gives the reason as "Potential safety issue due to a required torque check on three bolted joints of the Revolution CT scanner. No injuries or illnesses reported". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0985-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-19
Posted: 2015-01-15
Terminated: 2015-04-29
Recalling firm: GE Healthcare
Product: GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.
Product code: JAK System, X-Ray, Tomography, Computed
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were sent on 12/19/2014 a GE Healthcare "Urgent Medical Device Correction" letter GEHC # 25457 dated December 19, 2014. The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology / Cardiology and Radiologists / Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (US phone 800-437-1171, Japan 0120-055-919, other countries contact your local GE Healthcare Service Representative).
Quantity in commerce: 13 (7 US, 6 OUS)
Distribution: US: FL, WA, IL, UT, NY, CA. OUS: Canada, France, Hong Kong, Japan, Switzerland, United Arab Emirates.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0985-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0985-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-15

Product code JAK

K133705Class IIRevolution CTGe Medical Systems, LLC / cleared 2014-04-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)