Recall Z-1130-2021— GE Healthcare, LLC
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2020-12-17, terminated 2023-01-09. It names 3 FDA 510(k) clearances: K191777, K163213, K133705. Product: System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.. Reason: GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the table pinch protector could be damaged or missing leading to exposed table screws which could cause a laceration due to a sharp edge..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-12-17
- Terminated
- 2023-01-09
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
3 on FDA's record- K191777 — Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
- K163213 — Revolution CT
- K133705 — REVOLUTION CT
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
System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.
Reason for recall
GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the table pinch protector could be damaged or missing leading to exposed table screws which could cause a laceration due to a sharp edge.
Data sourced from openFDA. This site is unofficial and independent of the FDA.