Reported Sep 5, 2012 · Terminated
OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat;…
GE OEC Medical Systems, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE OEC Medical Systems, Inc · 384 Wright Brothers Dr · Salt Lake City, UT · 84116-2862
Is this the product you have?
7 of 7 products
| # | Product as published |
|---|---|
| 1 | OEC IT3000 |
| 2 | IT2500 (EnTrak) |
| 3 | IT2500 Plus (EnTrak Plus) |
| 4 | IT3500 (InstaTrak) |
| 5 | IT3500 Plus (InstaTrak Plus) |
| 6 | ConneCTstat |
| 7 | 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 technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MRI, or X-ray. |
- Lot codes and dates
- All serial numbers.
- Amount recalled
- 768 units
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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