GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.
FDA device recall Z-0985-2015 · posted 2015-01-15 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- 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.
- Action taken
- 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).
- Root cause
- Process control
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 13 (7 US, 6 OUS)
- Distribution
- US: FL, WA, IL, UT, NY, CA. OUS: Canada, France, Hong Kong, Japan, Switzerland, United Arab Emirates.
- Date initiated
- 2014-12-19
- Date posted
- 2015-01-15
- Date terminated
- 2015-04-29
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REVOLUTION CT (K133705) | Ge Medical Systems, LLC | 2014-04-11 |