Recall Z-1583-2025— Philips Medical Systems Nederland B.V.
Class II · Ongoing
Class II FDA medical device recall by Philips Medical Systems Nederland B.V., initiated 2023-07-20. It names 2 FDA 510(k) clearances: K212813, K183040. Product: Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.. Reason: Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch..
- Recalling firm
- Philips Medical Systems Nederland B.V.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-07-20
- Firm location
- Eindhoven, N/A, Netherlands
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.
Reason for recall
Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.
Data sourced from openFDA. This site is unofficial and independent of the FDA.