Device recall

Z-0311-2018: Mobile Detector Holder - Stationary X-ray System (RF System). suitable for…

FDA device recall · Class II · Philips Electronics North America Corporation

Key facts

Recall number (Z-number) Z-0311-2018
Recall event 78833
Product Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable detector free in the room for X-ray exposures. It supports the wireless portable detector with or without a grid.
Product code KPR
Recalling firm Philips Electronics North America Corporation
Recall class Class II
Status Terminated
Termination date Jun 5, 2020
510(k) numbers K031535
FEI number 1218950

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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