Recall Z-1589-2016— GE Medical Systems, LLC
Class II · Terminated
Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2016-04-20, terminated 2016-09-21. It names one FDA 510(k) clearance: K133705. Product: GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications. Reason: 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..
- Recalling firm
- GE Medical Systems, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-04-20
- Terminated
- 2016-09-21
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.