Xray Fluoro Angio Stationary Digital

Siemens Healthcare GmbH is recalling X-ray fluoroscopy angiography stationary digital devices distributed to hospitals, pharmacies, and laboratories in New Zealand due to a software issue that requires an upgrade. This is a Class I recall, which means the device could cause serious health problems or death. The recall affects medical facilities that received these devices in New Zealand.

Recalling firm

Siemens Healthcare (NZ) Ltd

Product

Xray fluoro angio stationary digital. [Device]. Model: ARTIS icono floor, ARTIS icono biplane, ARTIS icono ceiling delivered with software version VE40A and VE40B. Affected: Catalogue - 11327600, 11328100, 11327700

Reason

The manufacturer has identified that in rare situations, after increasing the detector lift height to its maximum or minimum, the system may lose its movement capability. A reboot may not reestablish movement control. This failure can be resolved only by qualified service personnel., If this problem occurs, the system will report a failure of movement control and request a service call. It will not be possible, to move the stand other than by emergency salvage procedures. Manual unmotorised table movements as well as fluoroscopy and, acquisition will be still available. This may result in...

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-05-22

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/f0e15c41-8154-4a11-be0f-402eb16d81ce