Device recall

Z-1126-03: Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4 --- Common…

FDA device recall · Class III · Olympus America Inc.

Key facts

Recall number (Z-number) Z-1126-03
Recall event 26637
Product Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4 --- Common name: Medical image storage device. Class I, 510 (k) exempt.
Product code LMB
Recalling firm Olympus America Inc.
Recall class Class III
Status Terminated
Termination date Mar 22, 2005
510(k) numbers K934888, K934889
FEI number 2429304

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)