Recall Z-1511-2022— GE Healthcare, LLC
Class II · Ongoing
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2022-06-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High Capacity Table, Lite Table, Kunlun Table, Global PET-CT Table, NP Table, P2005AA Table, LCT Table, CTE TWIN TABLE Assy. All devices are patient tables for PET/CT systems.. Reason: As a result of unclear guidance in the service manual, the table can drop during a specific service activity if the wrong screws are removed by the service personnel without the appropriate table supports in place resulting in injury to service personnel..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-06-02
- Firm location
- Waukesha, WI, United States
Product description
Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High Capacity Table, Lite Table, Kunlun Table, Global PET-CT Table, NP Table, P2005AA Table, LCT Table, CTE TWIN TABLE Assy. All devices are patient tables for PET/CT systems.
Reason for recall
As a result of unclear guidance in the service manual, the table can drop during a specific service activity if the wrong screws are removed by the service personnel without the appropriate table supports in place resulting in injury to service personnel.
Data sourced from openFDA. This site is unofficial and independent of the FDA.