Artis Pheno And Artis Icono Systems

Siemens Healthcare is recalling ARTIS pheno and ARTIS icono systems distributed to hospitals, pharmacies, and laboratories in New Zealand due to a software issue that requires an upgrade. This is classified as a Class I recall, which is the most serious type. The recall affects medical imaging systems that were distributed in New Zealand healthcare settings.

Recalling firm

Siemens Healthcare (NZ) Ltd

Product

ARTIS pheno and ARTIS icono systems. [Device]. Model: Catalogue numbers - 11328100, 10849000, 11327700, 11327600. Affected: ARTIS pheno, ARTIS icono with VE30B and VE40B

Reason

The manufacturer has identified that the ARTIS pheno, ARTIS icono with VE30B and VE40B – Incorrectly Reported DAP value. During examination, the system may show sporadically:, 1. that zero dose is administered to the patient. This sporadic behavior is only shown in fluoroscopy and/or acquisitions with one (single) frame. The dose reported is "0", but dose is actually administered to the patient. OR, 2. that a major increase in the dose administered to the patient. The dose reported is significantly higher than the dose actually administered to the patient.

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-03-30

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/23918dc8-e602-46ae-9865-49ea67e73b1b