Device recall

Z-0290-04: Pulsox-3iA. LCD, Sp02, PR, Pulse strength bar, motion artifact, low battery…

FDA device recall · Class II · Minolta Corp

Key facts

Recall number (Z-number) Z-0290-04
Recall event 27692
Product Pulsox-3iA. LCD, Sp02, PR, Pulse strength bar, motion artifact, low battery message, error message, low Sp02 message, event mark. Measuring range Sp02 0 to 100, pulse rate 20 to 250, measuring accuracy Sp02 +/-2% (70 to 100), pulse rate +/- 2, Sp02 alarm, audible and visible, probe type finger…
Product code DQA
Recalling firm Minolta Corp
Recall class Class II
Status Terminated
Termination date Apr 14, 2004
510(k) numbers K010413
FEI number 1000136179

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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