Device recall

Z-1196-2010: Heartstart HS1 Defibrillator Model M5068A

FDA device recall · Class II · Philips Medical Systems

Key facts

Recall number (Z-number) Z-1196-2010
Recall event 53816
Product Heartstart HS1 Defibrillator Model M5068A
Product code NSA
Recalling firm Philips Medical Systems
Recall class Class II
Status Terminated
Termination date May 23, 2013
510(k) numbers K040904
FEI number 1000524572

At a glance

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