Medical device licence · 103868 · Class 3
ZENITION 50
Yes: licensed in Canada
Licence status Issued (active); first licensed November 19, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 103868
- Licence holder
- Philips Medical Systems Nederland B.V.Orange Village, OH, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- November 19, 2019
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- IMAGE INTENSIFIER
- ZENITION 50
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “zenition”. A notice may cover another product or only some lots: read it to see what it covers.
- Zenition 50October 15, 2025 · Radiology · Performance · Type II
- Zenition 70 and 50October 10, 2024 · Radiology · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.