Device recall

Z-0708-2025: Monitoring Service Application (MSA). Software to process, analyze, display, and…

FDA device recall · Class I · Braemar Manufacturing, LLC

Key facts

Recall number (Z-number) Z-0708-2025
Recall event 95837
Product Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
Product code DPS
Recalling firm Braemar Manufacturing, LLC
Recall class Class I
Status Open, Classified
FEI number 3003584029

At a glance

  • None 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

Browse all FDA device recalls (products)