Recall Z-2189-2017— GE Healthcare, LLC
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2017-05-19, terminated 2018-07-29. It names 2 FDA 510(k) clearances: K082104, K060052. Product: GE Healthcare Lightspeed RT16 X-ray system. Reason: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-19
- Terminated
- 2018-07-29
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
2 on FDA's record- K082104 — GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM
- K060052 — GE LIGHTSPEED XTRA CT SCANNER SYSTEM
K-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 Healthcare Lightspeed RT16 X-ray system
Reason for recall
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
Data sourced from openFDA. This site is unofficial and independent of the FDA.