Senographe Pristina Via Systems
- Recalling firm
- GE Healthcare Limited
- Product
- Senographe Pristina VIA systems. [Device]. Model: Senographe Pristina VIA 3D+2D. Affected: Certain clauses of IEC60601-2-45 Edition 3.1/3.2 standard
- Reason
- The manufacturer has become aware of a nonconformance to certain clauses of IEC60601-2-45 Edition 3.1/3.2 standard in some Senographe Pristina VIA systems., Specifically, in cases of 3D+2D manual mode where the acquisition configuration of the anode track/filter combination is different, it can result in the following:, � the collimator blades might be visible in the image, or the collimator might be open more than expected, and, � an incorrect collimator filter might be used with respect to the anode track selected, This issue could result in a minor additional X-ray dose being delivered...
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-10-13
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/d181ff1a-ab0c-4472-b872-08d92f351083