Device recall

Z-1605-2011: Philips BV Pulsera, Rel. 2.3, 718095. Mobile C-Arm X-Ray systems offering…

FDA device recall · Class II · Philips Medical Systems North America Co. Phillips

Key facts

Recall number (Z-number) Z-1605-2011
Recall event 57611
Product Philips BV Pulsera, Rel. 2.3, 718095. Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety of applications.
Product code IXL
Recalling firm Philips Medical Systems North America Co. Phillips
Recall class Class II
Status Terminated
Termination date Feb 28, 2012
510(k) numbers K010435
FEI number 1000524572

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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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