Recall Z-1511-2022 ยท IZZ Table, Radiographic, Non-Tilting, Powered
GE Healthcare, LLC
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.
| Date | Aug 10, 2022 (initiated Jun 2, 2022) |
| Status | Open, Classified |
| 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. |
| Root cause | Error in labeling |
| Action | The recalling firm issued letters dated 6/2/2022 via traceable means on 6/2/2022 to the following titles within the direct accounts: Director of Clinical / Radiology, Risk Manager / Hospital Administrator, and Director of Biomedical Engineering. The letter explained the safety issue that the table could 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. The letter reported there is no defect in the table itself and the issue is related to unclear guidance |
| Quantity | 24,843 tables |
| Distribution | US Nationwide distribution including PR. There was also government/military distribution. The countries of Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Plurinational State of Bolivia, Bosnia and Herzegovina |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.