Recall Z-1056-2019— Philips North America, LLC

Name: FDA recall Z-1056-2019
Creator: U.S. Food and Drug Administration
Published: 2019-02-28

Class II · Terminated

Class II FDA medical device recall by Philips North America, LLC, initiated 2019-02-28, terminated 2020-08-03. It names one FDA 510(k) clearance: K032046. Product: URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include: Gastro-intestinal examination Urography Bronchography Arthrography Hysterography Myelography Lymphography Skeletal radiography Tomography Venography/phlebography Special procedures that require subtracted and non-subtracted digital imaginginclude: Angiography Peripheral angiography (bolus chasing) Vascular and non-vascular interventional procedures.. Reason: The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user..

Recalling firm: Philips North America, LLC
Classification: Class II
Status: Terminated
Initiated: 2019-02-28
Terminated: 2020-08-03
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K032046 — PHILLIPS OMNIDIAGNOST ELEVAPhilips Medical Systems, Inc.·cleared 2003-07-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include: Gastro-intestinal examination Urography Bronchography Arthrography Hysterography Myelography Lymphography Skeletal radiography Tomography Venography/phlebography Special procedures that require subtracted and non-subtracted digital imaginginclude: Angiography Peripheral angiography (bolus chasing) Vascular and non-vascular interventional procedures.

Reason for recall

The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.

Data sourced from openFDA. This site is unofficial and independent of the FDA.