Ysio X.pree Va20g With X.wi-d Detectors Digital Stationary Xray

Siemens Healthcare is recalling YSIO X.pree VA20G digital X-ray systems equipped with X.wi-D detectors that were distributed to hospitals and laboratories in New Zealand. The systems require a software upgrade to address an unspecified issue. This is classified as a Class I recall, the most serious classification.

Recalling firm

Siemens Healthcare (NZ) Ltd

Product

YSIO X.pree VA20G with X.wi-D detectors digital stationary Xray. [Device]. Model: YSIO X.pree - with software version VA20G and X.wi-D detectors

Reason

In rare cases and under specific acquisition conditions involving X.wi-D detectors, the system may become unresponsive, most commonly during patient examinations that include free exposures. A system restart is required to restore operations. In some cases, the image acquired immediately before the system freeze may not be recoverable, resulting in an image loss and the necessity to repeat the exposure. Image acquisitions with MAX wi-D detectors are not affected by this problem. The manufacturer is preparing a software update (VA20H) for the YSIO X.pree system that will resolve this problem.

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-03-24

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/991b2a23-eff5-4c6e-83d7-5a2157873fcb