Recall Z-1441-2015— GE Healthcare
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, initiated 2015-03-09, terminated 2015-12-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.. Reason: GE Healthcare has recently become aware of an improper installation of a ceiling suspended pendent supporting a radiation shield and/or surgical lamp. The pendent system was not installed per specified installation requirements. There has been a reported incident of a radiation shield falling from the ceiling causing a minor injury..
- Recalling firm
- GE Healthcare
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-09
- Terminated
- 2015-12-21
- Firm location
- Waukesha, WI, United States
Product description
Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.
Reason for recall
GE Healthcare has recently become aware of an improper installation of a ceiling suspended pendent supporting a radiation shield and/or surgical lamp. The pendent system was not installed per specified installation requirements. There has been a reported incident of a radiation shield falling from the ceiling causing a minor injury.
Data sourced from openFDA. This site is unofficial and independent of the FDA.