Siemens Healthineers Ag - Class Iia - Gmdn 58250
- Recalling firm
- Siemens Healthcare (NZ) Ltd
- Product
- Siemens Healthineers AG - Class IIa - GMDN 58250. [Device]. Also covers: Siemens Healthcare GmbH (MDR), MRI system
- Reason
- A software issue has been identified in syngo.via MR Cardiac Analysis MR Flow Quantification when Beat Sensor triggering is used for retrospectively gated 2D cardiac flow examinations. The issue affects specified MAGNETOM MR and BIOGRAPH One PET/MR scanner models operating with certain software versions and licences.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-10-27
- Status
- Ongoing
- Distribution
- New Zealand
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/9f4370d0-56f9-452a-9bf3-0e0f85531251