Device recall

Z-0545-04: Datex-Ohmeda S/5 and AS/3 Anesthesia Delivery Units (The S/5 units are a later…

FDA device recall · Class II · Datex-Ohmeda Inc

Key facts

Recall number (Z-number) Z-0545-04
Recall event 28182
Product Datex-Ohmeda S/5 and AS/3 Anesthesia Delivery Units (The S/5 units are a later version of the AS/3 units. The conversion from AS3 to S5 occurred during the summer of 2000. This change was mainly a product name change, with a slight color variation to the shade of white being used externally on the…
Product code BSZ
Recalling firm Datex-Ohmeda Inc
Recall class Class II
Status Terminated
Termination date Nov 17, 2005
510(k) numbers K973985
FEI number 2183066

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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

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