Device recall

Z-2113-2010: BleaseSirius Anaesthesia System, gas machine. Blease Beech House, Chiltern Court…

FDA device recall · Class II · Spacelabs Healthcare, Llc

Key facts

Recall number (Z-number) Z-2113-2010
Recall event 56057
Product BleaseSirius Anaesthesia System, gas machine. Blease Beech House, Chiltern Court Asheridge Road, Chesham, Bucks HP5 2PX, England Intended for use in the hospital environment and operating room.
Product code BSZ
Recalling firm Spacelabs Healthcare, Llc
Recall class Class II
Status Terminated
Termination date Dec 3, 2010
510(k) numbers K051629
FEI number 3010157426

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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