Recall Z-2251-2012 ยท LLZ System, Image Processing, Radiological
GE OEC Medical Systems, Inc
OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat; and ConneCTstat Plus picture archiving and communications systems. The systems are an aid to locate anatomical structures during open or percutaneous surgical procedures. It is intended for use in medical conditions that may benefit from the use of stereotactic surgical techniqu
| Date | Aug 28, 2012 (initiated Jun 22, 2009) |
| Status | Terminated |
| Reason | GE Healthcare Surgery had discovered that using the Inverted Headset Placement is not a validated configuration with the IT 3000, 2500, 2500 plus, 3500, 3500 plus, ConneCTstat, and ConneCTstat Plus Surgical Navigation equipment. |
| Root cause | Labeling False and Misleading |
| Action | GE Healthcare sent an Urgent Safety Advisory Notice dated June 22, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised not to use the ENT registration Headset in the inverted position for any CT scans or surgical procedures and to remove all references in their Naviation System Operator's Manual that discuss an inverted headset placement, and replace it with the enclosed updated instructions for the Navigation System Operator's Manual. For any questions customers should contact the service team f |
| Quantity | 768 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of India, Japan, Canada, Switzerland, Italy, United Kingdom, Germany, Austria, Hong Kong, France, and Denmark. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960330 | INSTATRAK Visualization Technology, Inc., Apr 8, 1996 |
| K981998 | PEDIATRIC INSTATRAK SYSTEM Visualization Technology, Inc., Aug 21, 1998 |
| K982994 | SKULL BASE INSTATRAK SYSTEM Visualization Technology, Inc., Nov 16, 1998 |
| K983529 | INSTATRAK 3000 Visualization Technology, Inc., Dec 31, 1998 |
| K990919 | STRAIGHT ASPIRATOR, 90 DEGREE ASPIRATOR,45 DEGREE ASPIRATOR,7 FRENCH ASPIRATOR,EXTENDED STRAIGHT ASPIRATOR,13.9 CM STRAG Visualization Technology, Inc., Apr 15, 1999 |
| K994270 | INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000 Visualization Technology, Inc., Mar 9, 2000 |