Class 2 Device Recall Mobile fluoroscopic xray unit.

• Date Initiated by Firm: July 06, 2007
• Date Posted: July 12, 2007
• Recall Status: Terminated on February 01, 2013
• Recall Number: Z-0990-2007
• Recall Event ID: 38339
• 510(K)Number: K024012
• Product Classification: fluoroscopic x-ray - Product Code JAA
• Product: GEHC OEC 9800 ESP-15 C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, UT.
• Code Information: Serial numbers: 8S-2329, 8S-3288-H, 8S-7232-MH, 89-3562.
• Recalling Firm/ Manufacturer: GE OEC Medical Systems, Inc; 384 Wright Brothers Dr; Salt Lake City UT 84116-2862
• For Additional Information Contact: 801-328-9300
• Manufacturer Reason for Recall: The Air Kerma Rate displayed value and cumulative air kerma displayed value could exceed the allowable error under certain imaging conditions.
• FDA Determined Cause: Other
• Action: Consignees were notified by certified letter on 07/06/2007. They were told that a service rep would contact them to provide a label and an addendum to their operator's manual. A permanent software solution is under development and will be provided when it becomes available.
• Quantity in Commerce: 4 units
• Distribution: Worldwide, including USA, France, Singapore, Sweden, and Switzerland.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JAA