—#132214

Product

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

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 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

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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).

Recalling firm

Firm: GE Healthcare
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

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

Timeline

Recall initiated: 2014-12-19
Posted by FDA: 2015-01-15
Terminated: 2015-04-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132214. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.