PlainRecalls
FDA Devices Moderate Class II Terminated

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 no

Reported: April 3, 2019 Initiated: February 28, 2019 #Z-1056-2019

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.

Details

Units Affected
1969
Distribution
US Nationwide domestic distribution, and worldwide international distribution.
Location
Andover, MA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Philips North America, LLC. Units affected: 1969.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 3, 2019. Severity: Moderate. Recall number: Z-1056-2019.

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