Device recall

Z-0606-2013: GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal…

FDA device recall · Class I · GE Healthcare, LLC

Key facts

Recall number (Z-number) Z-0606-2013
Recall event 63123
Product GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece Disposable Circuit Kit with Mask Size O; M1091365 QTY: 10 T-Piece Disposable Circuit Kit with Mask…
Product code BTL
Recalling firm GE Healthcare, LLC
Recall class Class I
Status Terminated
Termination date Apr 14, 2014
510(k) numbers K070210
FEI number 2126677

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)