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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus ImageManager Software

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 Class 2 Device Recall Olympus ImageManager Softwaresee related information
Date Initiated by FirmAugust 19, 2003
Date PostedOctober 15, 2003
Recall Status1 Terminated 3 on March 22, 2005
Recall NumberZ-0047-04
Recall Event ID 27169
510(K)NumberK934888 K934889 
Product Classification Device, Digital Image Storage, Radiological - Product Code LMB
ProductBrand name: Olympus ImageManager Software, Versions 6.0 through 6.4.1 (excluding version 6.3.8) Common name: Medical image storage device. Class I, 510 (k) exempt. (NOTE: any ImageManager Software sold as a stand-alone system is not impacted by this software malfunction since no opportunity exists for any image cross-linking. It is a condition of the software malfunction that the observed image crosslink results from the collision of data files from two separate ImageManager computers.)
Code Information Versions 6.0 through 6.4.1 (excluding version 6.3.8)
Recalling Firm/
Manufacturer		 Olympus America Inc.
Two Corporate Center Drive
Melville NY 11747
For Additional Information ContactLaura Storms-Tyler
631-844-5688
Manufacturer Reason
for Recall		Software malfunction; potential for simultaneous cross-linking of exam images to another patient's file.
FDA Determined
Cause 2		Other
ActionOAI sent "Urgent-Device Correction" letters, dated 8/19/03, to the end users, explaining the software malfunction. The letter also provided specific instructions to the end users until the software fix is installed. For technical assistance, users can contact OAI's Technical Assistance Center 1-800-848-9024. Accompanying the letter is a questionnaire to be completed by the end users & returned to OAI for scheduling an appointment to visit the facility to install the software fix.
Quantity in Commerce1014
DistributionMedical facilities (end users) nationwide and Puerto Rico, plus 5 foreign accounts located in Canada, Mexico, Ecuador and Chile.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LMB
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