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.
Reported: April 30, 2025 Initiated: July 20, 2023 #Z-1583-2025
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.
Details
- Recalling Firm
- Philips Medical Systems Nederland B.V.
- Units Affected
- 12 systems
- Distribution
- US Nationwide distribution
- Location
- Eindhoven, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Philips Medical Systems Nederland B.V.. Units affected: 12 systems.
Why was this product recalled? ▼
Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 30, 2025. Severity: Moderate. Recall number: Z-1583-2025.
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