FDA recall Z-1056-2019

Philips North America, LLC · Class II · device

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 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.

Distribution

US Nationwide domestic distribution, and worldwide international distribution.

Key facts

Status
Terminated
Initiation date
2019-02-28
Report date
2019-04-03
Termination date
2020-08-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1056-2019