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U.S. Department of Health and Human Services

Class 3 Device Recall Olympus ImageManager

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  Class 3 Device Recall Olympus ImageManager see related information
Date Initiated by Firm March 05, 2003
Date Posted August 12, 2003
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = OLYMPUS
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