Device recall

Z-1928-2011: Hamilton-G5 Ventilator with software version V2.00x and Neonatal Option or…

FDA device recall · Class II · Hamilton Medical Inc

Key facts

Recall number (Z-number) Z-1928-2011
Recall event 58014
Product Hamilton-G5 Ventilator with software version V2.00x and Neonatal Option or V2.01x and Neonatal software. Hamilton-G5: catalog number 159001; Neonatal Software catalog number: 159700; Neonatal Option catalog number: 159187. Hamilton Medical Intended for use in the hospital and institutional…
Product code CBK
Recalling firm Hamilton Medical Inc
Recall class Class II
Status Terminated
Termination date Mar 21, 2012
510(k) numbers K081521
FEI number 2937708

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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