Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High Cap

FDA device recall Z-1511-2022 · posted 2022-08-10 · Open, Classified

Recall details

Recalling firm

GE Healthcare, LLC

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.

Action taken

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 in the service manual for a specific service procedure. The issue can only occur during specific servicing activities on the table. To avoid the issue, the consignee is to contact GE Healthcare Service at the number provided in the letter prior to any table servicing activities so that GE Healthcare can provide the consignee with guidance. The letter contained a link to an acknowledgment form for completion. An appendix was enclosed which listed two tables, Table 1 listed the affected tables and Table 2 listed the affected CT (Computed Tomography), PET (Positron Emission Tomography) and NM (Nuclear Medicine) systems which use the tables. The letter informed the consignee that GE Healthcare will provide an updated service manual with specific instructions regarding safe servicing of the impacted tables. The service manual updates are planned to be released by the end of June 2022. Appendix B in the letter provides instructions on accessing the latest service manuals online.

Root cause

Error in labeling

Status

Open, Classified

Product code

IZZ

Quantity affected

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, Ba

Date initiated

2022-06-02

Date posted

2022-08-10

Location

Waukesha, WI