Class 3 Device Recall Olympus ImageManager

• Date Initiated by Firm: March 05, 2003
• Date Posted: August 12, 2003
• Recall Status: Terminated on March 22, 2005
• Recall Number: Z-1126-03
• Recall Event ID: 26637
• 510(K)Number: K934888 K934889
• Product Classification: Device, Digital Image Storage, Radiological - Product Code LMB
• Product: Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4 --- Common name: Medical image storage device. Class I, 510 (k) exempt.
• Code Information: Versions 6.0 through 6.4
• Recalling Firm/ Manufacturer: Olympus America Inc.; Two Corporate Center Drive; Melville NY 11747
• For Additional Information Contact: Laura Storms-Tyler; 631-844-5688
• Manufacturer Reason for Recall: Software defect; potential under certain circumstances to incorrectly identify endoscopy images that have been uploaded & saved to the network system.
• FDA Determined Cause: Other
• Action: Olympus America, Inc. sent "Urgent-Device Correction" letters, dated 3/5/03, to the medical facilities, advising them of the software malfunction. The letter provides instructions to health care practitioners and that a new software release is being developed to prevent a recurrence.
• Quantity in Commerce: 856
• Distribution: Medical facilities nationwide and Puerto Rico; and 4 foreign accounts in Canada, Ecuador, Chile & Mexico.
• 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 = LMB