GE OEC, InstaTrak 3500 Plus FluoroTrak and Fluoro CAT Spinal Applications used with Regular and Super 9800 and 9600 Arm
FDA device recall Z-0181-2008 · posted 2007-11-10 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems, Inc
- Reason for recall
- Tracking Accuracy - Image intensifier supplier's change on the C-Arm could lead to patient injury, due to incorrect anatomical location of the instrument during a procedure.
- Action taken
- Consignees were sent an Urgent Recall Notice letter, via mail dated 10/11/07, advising users to stop usage of the FluoroTrak and FluoroCAT spinal applications on the InstaTrak 3500 Plus System. Once a solution is identified, a representative will contact consignees to arrange for installation of the solution at no charge.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 61 units
- Distribution
- Class II Recall - Worldwide Distribution - USA including states of AZ, CA, FL, GA, IA, IL, KS, LA, MA, MD, MI, NC, NY, OK, PA, SC, TX, UT, VA, and WI, and countries of Canada, China, Germany, Hong Kon
- Date initiated
- 2007-03-23
- Date posted
- 2007-11-10
- Date terminated
- 2012-04-16
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
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|---|---|---|
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GP) 0.5-64 UG/ML (K050400) | Becton, Dickinson & CO | 2005-03-22 |