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Terminated

Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4 --- Common name: Medical image storage device. Class I, 510 (k) exempt.

FDA Recall Z-1126-03 · Posted 2003-08-12

Recalling FirmOlympus America Inc.
Recall StatusTerminated
Product CodeLMB
Date Initiated2003-03-05
Date Terminated2005-03-22
Product Quantity856

Reason for Recall

Software defect; potential under certain circumstances to incorrectly identify endoscopy images that have been uploaded & saved to the network system.

Firm 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.

Root Cause

Other

Distribution Pattern

Medical facilities nationwide and Puerto Rico; and 4 foreign accounts in Canada, Ecuador, Chile & Mexico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K934889OLYMPUS IMAGEMANAGER SYSTEMOlympus · 1994-01-28K934888OLYMPUS IMAGEMANAGERSYSTEMOlympus · 1994-01-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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