Device recall

Z-1272-2020: Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED…

FDA device recall · Class II · Philips North America LLC

Key facts

Recall number (Z-number) Z-1272-2020
Recall event 84850
Product Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063
Product code MKJ
Recalling firm Philips North America LLC
Recall class Class II
Status Terminated
Termination date Apr 29, 2024
510(k) numbers K020715, K040904, K050004
FEI number 1000524572

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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