Device recall

Z-0088-2017: SDMS (SenTec Digital Monitoring System)

FDA device recall · Class II · SenTec AG

Key facts

Recall number (Z-number) Z-0088-2017
Recall event 75257
Product SDMS (SenTec Digital Monitoring System)
Product code LKD
Recalling firm SenTec AG
Recall class Class II
Status Terminated
Termination date Jun 23, 2017
510(k) numbers K041548, K071672, K101690, K151329
FEI number 3004149774

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

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