Device recall

Z-0871-2014: ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is…

FDA device recall · Class II · Spacelabs Healthcare, Llc

Key facts

Recall number (Z-number) Z-0871-2014
Recall event 67243
Product ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.
Product code MHX
Recalling firm Spacelabs Healthcare, Llc
Recall class Class II
Status Terminated
Termination date Jun 12, 2014
510(k) numbers K121480
FEI number 3010157426

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

Browse all FDA device recalls (products)