GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applicat
FDA device recall Z-1589-2016 · posted 2016-04-29 · Terminated
Recall details
- Recalling firm
- GE Medical Systems, LLC
- 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.
- Action taken
- GE Healthcare Systems sent an Urgent Medical Device Correction letter dated April 20, 2016, to all affected consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 26 (US = 4;OUS = 22)
- Distribution
- 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, U
- Date initiated
- 2016-04-20
- Date posted
- 2016-04-29
- Date terminated
- 2016-09-21
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REVOLUTION CT (K133705) | Ge Medical Systems, LLC | 2014-04-11 |